U.S. patent application number 10/944270 was filed with the patent office on 2006-01-05 for apparatus and methods for dilating and modifying ostia of paranasal sinuses and other intranasal or paranasal structures.
This patent application is currently assigned to ExploraMed NC1, Inc.. Invention is credited to John Y. Chang, Joshua Makower, Julia D. Vrany, Amrish Jayprakash Walke.
Application Number | 20060004323 10/944270 |
Document ID | / |
Family ID | 36090513 |
Filed Date | 2006-01-05 |
United States Patent
Application |
20060004323 |
Kind Code |
A1 |
Chang; John Y. ; et
al. |
January 5, 2006 |
Apparatus and methods for dilating and modifying ostia of paranasal
sinuses and other intranasal or paranasal structures
Abstract
Sinusitis and other disorders of the ear, nose and throat are
diagnosed and/or treated using minimally invasive approaches with
flexible or rigid instruments. Various methods and devices are used
for remodeling or changing the shape, size or configuration of a
sinus ostium or duct or other anatomical structure in the ear, nose
or throat; implanting a device, cells or tissues; removing matter
from the ear, nose or throat; delivering diagnostic or therapeutic
substances or performing other diagnostic or therapeutic
procedures. Introducing devices (e.g., guide catheters, tubes,
guidewires, elongate probes, other elongate members) may be used to
facilitate insertion of working devices (e.g. catheters e.g.
balloon catheters, guidewires, tissue cutting or remodeling
devices, devices for implanting elements like stents,
electrosurgical devices, energy emitting devices, devices for
delivering diagnostic or therapeutic agents, substance delivery
implants, scopes etc.) into the paranasal sinuses or other
structures in the ear, nose or throat.
Inventors: |
Chang; John Y.; (Mountain
View, CA) ; Makower; Joshua; (Los Altos, CA) ;
Vrany; Julia D.; (Sunnyvale, CA) ; Walke; Amrish
Jayprakash; (Mountain View, CA) |
Correspondence
Address: |
Robert D. Buyan;Stout, Uxa, Buyan & Mullins, LLP
Suite 300
4 Venture
Irvine
CA
92618
US
|
Assignee: |
ExploraMed NC1, Inc.
Mountain View
CA
|
Family ID: |
36090513 |
Appl. No.: |
10/944270 |
Filed: |
September 17, 2004 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
10829917 |
Apr 21, 2004 |
|
|
|
10944270 |
Sep 17, 2004 |
|
|
|
Current U.S.
Class: |
604/28 ;
604/101.01; 604/96.01 |
Current CPC
Class: |
A61B 17/32002 20130101;
A61B 2018/00595 20130101; A61F 2/82 20130101; A61M 25/0147
20130101; A61M 2025/109 20130101; A61B 2017/22061 20130101; A61M
25/0026 20130101; A61M 2025/1079 20130101; A61M 2210/1028 20130101;
A61M 2210/0681 20130101; A61B 17/24 20130101; A61M 25/09 20130101;
A61M 25/005 20130101; A61M 25/1011 20130101; A61M 25/1006 20130101;
A61M 29/02 20130101; A61B 2034/2051 20160201; A61M 25/0102
20130101; A61M 25/0082 20130101; A61M 2025/0177 20130101; A61F
2/958 20130101; A61M 25/0138 20130101; A61B 18/1492 20130101; A61M
25/10 20130101; A61F 2/186 20130101; A61B 17/3421 20130101; A61B
5/6852 20130101; A61F 2/90 20130101; A61B 17/3403 20130101; A61B
2017/22051 20130101; A61B 2017/22039 20130101; A61M 2025/1072
20130101; A61F 2/95 20130101; A61M 2029/025 20130101; A61B
2018/00327 20130101 |
Class at
Publication: |
604/028 ;
604/096.01; 604/101.01 |
International
Class: |
A61M 1/00 20060101
A61M001/00; A61M 29/00 20060101 A61M029/00 |
Claims
1. A method for diagnosing and/or treating sinusitis or another
disorder affecting the nose, paranasal sinuses or other anatomical
structures of the ear, nose or throat in a human or animal subject,
said method comprising the steps of: a. providing an introducing
device that has a proximal end and a distal end; b. advancing the
introducing device through the nose and to a position near an
opening of a paranasal sinus; c. providing a working device that is
positionable in an operative location and useable to perform a
diagnostic or therapeutic procedure within the opening of the
paranasal sinus or within the paranasal sinus; d. using the
introducing device to facilitate advancement of the working device
to the operative location; and e. using the working device to
perform a diagnostic or therapeutic procedure within the opening of
the paranasal sinus or within the paranasal sinus.
2. A method according to claim 1 wherein the introducing device is
selected from the group consisting of: guide catheters, guide
catheters with a pre-set shape, steerable guide catheters,
steerable catheters, guidewires, guidewires with a pre-set shape,
steerable guidewires, ports, introducers and sheaths.
3. A method according to claim 1 wherein the introducing device is
a generally tubular introducing device having a lumen extending
therethrough and wherein the method further comprises the steps of:
providing a second introduction device and inserting the second
introduction device through the lumen of the generally tubular
introducing device; and wherein Step d comprises using the
introducing device and the second introducing device to facilitate
advancement of the working device to the operative location.
4. A method according to claim 3 wherein the second introduction
device is selected from the group consisting of: elongate guide
members, elongate probes, guidewires, steerable guidewires,
catheters and tubular members sized to be advanced through the
lumen of the tubular introduction device.
5. A method according to claim 3 wherein the second introduction
device is a guidewire and wherein the working device has a
guidewire receiving lumen that extends through at least a portion
of the working device such that the working device may be advanced
over the guidewire.
6. A method according to claim 5 wherein the guidewire is
steerable.
7. A method according to claim 1 wherein the opening of the
paranasal sinus is a natural ostium or duct of the paranasal
sinus.
8. A method according to claim 1 wherein the opening of the
paranasal sinus is an artificially created opening of the paranasal
sinus.
9. A method according to claim 8 wherein the opening is an
antrostomy opening formed in a maxillary sinus.
10. A method according to claim 8 wherein the artificially created
opening is created by using a device selected from the group
consisting of: needles, dissectors, punches, rotating drills,
corers, scalpels, burs, scissors, forceps, cutters, chompers,
radiofrequency ablation devices, microwave ablation devices, laser
devices, rotating blades and cutting balloons.
11. A method according to claim 1 wherein the method is performed
using a guidance method selected from the group consisting of
endoscopic guidance, fluoroscopic guidance, X-ray radiographic
guidance, ultrasound guidance, robotic guidance, radio-frequency
localization, electromagnetic sensing and positioning and 3-D
guidance.
12. A method according to claim 1 wherein the working device is
used to perform a procedure selected from the group consisting of:
a. delivering an imageable or traceable substance; b. delivering a
therapeutically effective amount of a therapeutic substance; c.
implanting a stent, tissue remodeling device, substance delivery
implant or other therapeutic apparatus; d. cutting, ablating,
debulking, cauterizing, heating, lasing, dilating or otherwise
modifying tissue; e. grafting or implanting cells or tissue; f.
reducing, setting, screwing, applying adhesive to, affixing,
decompressing or otherwise treating a fracture; g. delivering a
gene or gene therapy preparation; h. cutting, ablating, debulking,
cauterizing, heating, lasing, forming an osteotomy in or otherwise
modifying bony or cartilaginous tissue within paranasal sinus or
elsewhere within the nose; i. remodeling or changing the shape,
size or configuration of a sinus ostium or duct or other anatomical
structure that affects drainage from one or more paranasal sinuses;
j. remodeling or changing the shape, size or configuration of a
passage way other than a paranasal sinus within the nose or
nasopharynx. k. performing an antrostomy of a paranasal sinus; l.
performing an antrostomy of a maxillary meatus; m. performing a
sinusotomy of a paranasal sinus; n. performing an ethmoidectomy; o.
removing puss or aberrant matter from the paranasal sinus or
elsewhere within the nose; and p. scraping or otherwise removing
cells that line the interior of a paranasal sinus; q. removing all
or a portion of a tumor; r. removing a polyp; and s. delivering
histamine, an allergen or another substance that causes secretion
of mucous by tissues within a paranasal sinus to permit assessment
of drainage from the sinus.
13. A method according to claim 1 wherein the working device is
selected from the group consisting of balloon catheters, cutting
balloons, cutters, chompers, rotating cutters, rotating drills,
rotating blades, sequential dilators, tapered dilators, punches,
dissectors, burs, non-inflating mechanically expandable members,
high frequency mechanical vibrators, dilating stents and
radiofrequency ablation devices, microwave ablation devices, laser
devices, snares, biopsy tools, scopes and devices that introduce
diagnostic or therapeutic agents.
14. A method according to claim 1 wherein: Step d comprises
advancing a tube through the introducing device to a location
within a paranasal sinus; and Step e comprises delivering a
flowable contrast agent into a paranasal sinus through the tube and
subsequently imaging the flowable contrast agent to assess the
manner in which the flowable contrast agent drains from the
paranasal sinus.
15. A method according to claim 14 wherein the flowable contrast
agent has a viscosity similar to the viscosity of mucous.
16. A method according to claim 14 wherein the imaging is carried
out using an imaging apparatus that is moveable and wherein the
imaging apparatus is moved to different positions to different
vantage points relative to the patient's anatomy.
17. A method according to claim 1 wherein the working device
comprises a scope and wherein Step e comprises using the scope to
visualize structures within the nose and/or paranasal sinuses.
18. A method according to claim 13 wherein the scope is used to
guide, facilitate or verify positioning of another working
device.
19. A method according to claim 1 wherein the method further
comprises the step of inserting a scope into the nose or nasal
cavity or paranasal sinus and using the scope to view at least a
portion of the procedure.
20. A method according to claim 1 wherein the working device
comprises a balloon catheter that has a flexible catheter shaft and
a balloon on said catheter shaft.
21. A method according to claim 20 wherein the catheter shaft
comprises at least one flexible region of flexural stiffness less
than 200 pound-force per inch for a flexible region length of one
inch.
22. A method according to claim 17 wherein the scope is used to
guide, facilitate or verify positioning of a guide catheter and
wherein another working apparatus is then advanced through the
guide catheter after the guide catheter has been positioned.
23. A method for performing a diagnostic or therapeutic procedure
within the paranasal sinuses, ear, nose or throat of a human or
animal subject, said method comprising the steps of: A) providing
an working device that is trans-nasally insertable into the nose,
paranasal sinuses or other anatomical structure of the ear, nose or
throat, said working device comprising an elongate flexible shaft,
at least one stiffening element for temporarily stiffening said
flexible shaft and a working part useable to perform the diagnostic
or therapeutic procedure; B) trans-nasally advancing the working
device to an operative position within the nose, paranasal sinuses,
ear, nose or throat; and C) using the working part to perform the
diagnostic or therapeutic procedure; wherein, the stiffening
element is used to stiffen the flexible shaft of the working device
during at least a portion of the procedure.
24. A method according to claim 23 wherein the working device is a
balloon catheter having a flexible catheter shaft, a stiffening
element for temporarily stiffening the catheter shaft and a
balloon.
25. A method according to claim 24 wherein Step C comprises
advancing the balloon catheter to a position within the ostium of a
paranasal sinus or within a paranasal sinus and therafter inflating
the balloon.
26. A method according to claim 25 wherein the stiffening element
is used to stiffen the catheter shaft during the insertion and
positioning of the catheter and is subsequently removed after the
catheter has been positioned within the ostium or paranasal
sinus.
27. A method according to claim 24 wherein the stiffening element
comprises a stylet that is insertable into at least a portion of
the catheter shaft to impart stiffness thereto.
28. A method according to claim 24 wherein the stiffening element
comprises a stiffening member that is attachable to and removable
from at least a portion of the flexible catheter shaft.
29. A method according to claim 24 wherein the stiffening element
comprises a sleeve that is temporarily positionable over at least a
portion of the flexible catheter shaft to impart stiffness
thereto.
30. A method for diagnosing and/or treating sinusitis or another
disorder affecting the nose, paranasal sinuses or other anatomical
structures of the ear, nose or throat, said method comprising the
steps of: a. providing an working device comprising a proximal end;
a distal end; at least one stiffening element between the proximal
end and the distal end wherein the stiffening element is selected
from the group consisting of spiral wires, braids, stiffening
wires, stiffening rings, stiffening coatings, stiffening meshes,
controllably stiffening elements, insertable or removable
stiffening elements; and a working element on or near the distal
end; b. advancing the working device in a nasal cavity so that the
distal end of the working device is in the vicinity of an opening
of a paranasal sinus; and c. performing a diagnostic or therapeutic
procedure using the working device.
31. The method according to claim 30 wherein the working element is
selected from the group consisting of inflatable balloons, rotating
cutters, high frequency mechanical vibrators, rotating drills,
sequential dilators, tapered dilators, punches, electrocautery
devices, cutters, mechanically expandable members, dilating stents
and devices that introduce diagnostic or therapeutic agents.
32. A method for diagnosing and/or treating sinusitis or another
disorder affecting the nose, paranasal sinuses or other anatomical
structures of the ear, nose or throat, said method comprising the
steps of: A) providing an working device comprising a proximal end;
a distal end; at least one flexible element between the proximal
end and the distal end, wherein the flexible element is selected
from the group consisting of shape memory elements, braided
elements, spiral elements, coated elements, ringed elements,
elastic elements, super elastic elements, controllably stiffening
elements; and a working element on or near the distal end, wherein
the working element is selected from the group consisting of
balloon catheters, rotating cutters, high frequency mechanical
vibrators, rotating drills, sequential dilators, tapered dilators,
punches, electrocautery devices, cutters, mechanically expandable
members, dilating stents and devices that introduce diagnostic or
therapeutic agents; B) advancing the working device in a nasal
cavity so that the distal end of the working device is in the
vicinity of an opening of a paranasal sinus; and C) performing a
diagnostic or therapeutic procedure using the working device.
33. A system for diagnosing and/or treating sinusitis or another
disorder affecting the nose, paranasal sinuses or other anatomical
structures of the ear, nose or throat comprising: an introducing
member comprising a proximal end and a distal end for insertion
into in a nasal cavity; and a working device that can be advanced
along the introducing member.
34. The system according to claim 33 wherein the introducing member
is selected from the group consisting of catheters, guide
catheters, guide catheters with a pre-set shape, steerable guide
catheters, steerable catheters, guidewires, guidewires with a
pre-set shape, steerable guidewires, ports, introducers and
sheaths.
35. The system according to claim 33 wherein the introducing member
is a guide catheter comprising a proximal end and a distal end and
a lumen extending from the proximal end to the distal end and
wherein the system further comprises a guidewire that can be
inserted through the lumen of the guide catheter.
36. The system according to claim 33 wherein the nasal cavity is a
natural ostium of a paranasal sinus.
37. The system according to claim 33 wherein the nasal cavity is an
artificially created opening of a paranasal sinus.
38. The system according to claim 37 wherein the artificially
created opening of the paranasal sinus is created by using a device
selected from the group consisting of needles, dissectors, punches,
drills, corers, scalpels, burs, scissors, forceps and cutters.
39. The system according to claim 33 wherein the method is
performed using a guidance method selected from the group
consisting of endoscopic guidance, fluoroscopic guidance, X-ray
radiographic guidance, ultrasound guidance, robotic guidance,
radio-frequency visualization, and 3-D guidance.
40. The system according to claim 33 wherein the working device is
used to perform a procedure selected from the group consisting of:
delivering an imageable or traceable substance; delivering a
therapeutically effective amount of a therapeutic substance;
implanting a stent, tissue remodeling device, substance delivery
implant or other therapeutic apparatus; cutting, ablating,
debulking, cauterizing, heating, lasing, dilating or otherwise
modifying tissue; grafting or implanting cells or tissue; reducing,
setting, screwing, applying adhesive to, affixing, decompressing or
otherwise treating a fracture; delivering a gene or gene therapy
preparation; cutting, ablating, debulking, cauterizing, heating,
lasing, forming an osteotomy in or otherwise modifying bony or
cartilaginous tissue within paranasal sinus or elsewhere within the
nose; remodeling or changing the shape, size or configuration of a
sinus ostium or duct or other anatomical structure that affects
drainage from one or more paranasal sinuses; remodeling or changing
the shape, size or configuration of a passage way other than a
paranasal sinus within the nose or nasopharynx. performing an
antrostomy of a paranasal sinus; performing an antrostomy of a
maxillary meatus; performing a sinusotomy of a paranasal sinus;
performing an ethmoidectomy; removing puss or aberrant matter from
the paranasal sinus or elsewhere within the nose; and scraping or
otherwise removing cells that line the interior of a paranasal
sinus; removing all or a portion of a tumor; removing a polyp; and
delivering histamine, an allergen or another substance that causes
secretion of mucous by tissues within a paranasal sinus to permit
assessment of drainage from the sinus; delivering a flowable
contrast agent into a paranasal sinus and subsequently imaging the
flowable contrast agent to assess the manner in which the flowable
contrast agent drains from the paranasal sinus.
41. The system according to claim 40 wherein the flowable contrast
agent has a viscosity similar to the viscosity of mucous.
42. A method according to claim 40 wherein the imaging of the
flowable contrast agent is carried out using an imaging apparatus
that is moveable and wherein the imaging apparatus is moved to
different positions to different vantage points relative to the
patient's anatomy.
43. The system according to claim 33 wherein the working device is
used to remodel or change the shape, size or configuration of a
natural or artificially created passage way within the nose or
nasopharynx using a device selected from the group consisting of
balloon catheters, rotating cutters, rotating brushes, rotating
drills, high frequency mechanical vibrators, sequential dilators,
tapered dilators, swellable dilators, punches, radiofrequency
ablation devices, microwave ablation devices, cutters, mechanically
expandable members, dilating stents and devices that introduce
diagnostic or therapeutic agents.
44. The system according to claim 33 wherein the working device
comprises a scope inserted into the nose or paranasal sinus to
visualize structures within the nose and/or paranasal sinuses.
45. The system according to claim 44 wherein the scope is used to
guide, facilitate or verify positioning of another working
device.
46. The system according to claim 33 wherein the working device
comprises a balloon catheter.
47. The system according to claim 46 wherein the balloon catheter
comprises a balloon that can be inflated in steps so that the
diameter of the balloon increases in steps of 0.5 mm till a maximum
balloon diameter of 20 mm.
48. The system according to claim 46 wherein the length of the
balloon catheter is from 4 inches to 10 inches.
49. The system according to claim 46 wherein the balloon of the
balloon catheter has an asymmetrical crossection.
50. The system according to claim 46 wherein the balloon of the
balloon catheter is inflated by an inflation medium selected from
the group consisting of water, saline, radiographic contrast
material, therapeutic substance, ultrasound echogenic material,
heat conducting fluid and electricity conducting fluid.
51. The system according to claim 46 wherein the balloon of the
balloon catheter is inflated by inflation means selected from the
group consisting of hydraulic inflation means; and sequential
inflation means through a plurality of balloon inflation ports.
52. The system according to claim 46 wherein the balloon of the
balloon catheter is selected from the group consisting of straight
balloons, spherical balloons, conical balloons, conical/square long
balloons, long spherical balloons, cylindrical balloons, curved
balloons, offset balloons, conical/offset balloons, square
balloons, conical/square balloons, conical/spherical long balloons,
tapered balloons, stepped balloons and dog bone balloons.
53. The system according to claim 46 wherein the balloon of the
balloon catheter is manufactured from a material selected from the
group consisting of polyethylene terephthalate, Nylon,
polyurethane, polyvinyl chloride, crosslinked polyethylene,
polyolefins, HPTFE, HPE, HDPE, LDPE, EPTFE, block copolymers, latex
and silicone.
54. The system according to claim 46 wherein the balloon catheter
comprises makers selected from the group consisting of radiographic
markers, visual markers, ultrasound markers, radiofrequency markers
and magnetic markers.
55. The system according to claim 46 wherein the balloon catheter
comprises sensors selected from the group consisting of
electromagnetic sensors, electrical sensors, magnetic sensors,
light sensors and ultrasound sensors.
56. The system according to claim 46 wherein the balloon catheter
is introduced into the target anatomy by an introducing method
selected from the group consisting of over-the-wire method, rapid
exchange method and no-wire method.
57. The system according to claim 46 wherein the balloon of the
balloon catheter is folded such that the folded balloon surface has
a configuration selected from the group consisting of a non-pleated
configuration, a multi-pleated configuration wherein the pleats are
oriented along the same tangential direction and a multi-pleated
configuration wherein at least two pleats are oriented along
opposite tangential directions.
58. The system according to claim 46 wherein the balloon of the
balloon catheter encloses a enclosed length of the working device
wherein the flexural stiffness of the enclosed length is less than
200 pound-force per inch for an enclosed length of one inch.
59. The system according to claim 46 wherein the balloon catheter
comprises a wire on the tip of the balloon catheter for navigation
through the anatomy.
60. The system according to claim 46 wherein the surface of the
balloon of the balloon catheter is coated with a coating selected
from the group consisting of hydrophilic lubricious coatings,
hydrophobic lubricious coatings, abrasion resisting coatings,
puncture resisting coatings, conductive coatings, radiopaque
coatings, echogenic coatings, thrombogenicity reducing coatings and
coatings that release drugs.
61. The system according to claim 60 wherein the coating on the
balloon is applied by a process selected from the group consisting
of dip application, bonding, impregnation, vapor deposition and
Ultraviolet curing.
62. The system according to claim 46 wherein material of the
balloon of the balloon catheter has a thickness from 0.0001 to 0.01
inches.
63. The system according to claim 46 wherein the balloon of the
balloon catheter has a burst pressure greater than 14
atmospheres.
64. The system according to claim 46 wherein the balloon of the
balloon catheter is designed such that when the balloon is inflated
to a burst pressure, the balloon bursts preferentially at a bond
between a proximal region of the balloon and the balloon
catheter.
65. The system according to claim 46 wherein the balloon catheter
comprises a stent for delivery into the anatomy before or after a
dilation procedure.
66. The system according to claim 46 wherein the balloon of the
balloon catheter comprises features on the exterior surface
selected from the group consisting of cutting blades and
ridges.
67. The system according to claim 46 wherein the balloon of the
balloon catheter comprises means for energy transfer.
68. The system according to claim 67 wherein the balloon of the
balloon catheter is used to transfer energy selected from the group
consisting of radiofrequency energy, thermal energy and electrical
energy.
69. The system according to claim 46 wherein the balloon of the
balloon catheter comprises reinforcement means selected from the
group consisting of reinforcing meshes, reinforcing coatings,
reinforcing braids, reinforcing wires, embedded reinforcing
filaments, reinforcing rings and reinforcing fabric, external or
internal reinforcing coils etc.
70. The system according to claim 46 wherein the balloon of the
balloon catheter comprises micropores on its surface for delivering
agents.
71. The system according to claim 46 wherein the shaft of the
balloon catheter is substantially stiff.
72. The system according to claim 46 wherein the shaft of the
balloon catheter comprises at least one plastically deformable
element.
73. The system according to claim 46 wherein the shaft of the
balloon catheter comprises at least one steerable or deflectable
element.
74. The system according to claim 46 wherein the shaft of the
balloon catheter comprises a material selected from the group
consisting of PeBax, Polyimide, Braided Polyimide, Polyurethane,
Nylon, PVC, Hytrel 8238, Teco 60D, metal wires like stainless steel
wires and Fluoropolymers like PTFE, PFA, FEP and ETFE.
75. The system according to claim 46 wherein the shaft of the
balloon catheter comprises at least one controllably stiffening
element.
76. The system according to claim 46 wherein the shaft of the
balloon catheter comprises a lumen selected from the group
consisting of end-to-end lumen, zipper lumen, rapid exchange lumen,
parallel lumen surrounded by a jacket and coaxial lumen.
77. The system according to claim 46 wherein the shaft of the
balloon catheter comprises a composite braid.
78. The system according to claim 77 wherein the composite braid
comprises a material selected from the group consisting of
stainless steel, Kevlar, Nitinol, Polyimide, Dacron, Nylon and
EPTFE.
79. The system according to claim 77 wherein the composite braid is
in a form selected from the group consisting of meshes, fabrics,
braids, coils, parallel members and rings.
80. The system according to claim 46 wherein the shaft of the
balloon catheter comprises a strain relief section.
81. The system according to claim 46 wherein the shaft of the
balloon catheter has varying stiffness along the length of the
shaft.
82. The system according to claim 46 wherein the shaft of the
balloon catheter comprises of at least one lumen of a substantially
non-circular cross-section.
83. The system according to claim 46 wherein the shaft of the
balloon catheter comprises a marker selected from the group
consisting of visual markers, radiographic markers, ultrasound
markers, radiofrequency markers and magnetic markers.
84. The system according to claim 46 wherein the shaft of the
balloon catheter comprises a coating on its outer surface selected
from the group consisting of hydrophilic lubricious coatings,
hydrophobic lubricious coatings, abrasion resisting coatings,
puncture resisting coatings, conductive coatings, radiopaque
coatings, echogenic coatings, thrombogenicity reducing coatings and
coatings that release drugs.
85. The system according to claim 84 wherein the coating is applied
by a process selected from the group consisting of dip application,
bonding, impregnation, vapor deposition and Ultraviolet curing.
86. The system according to claim 46 wherein the shaft of the
balloon catheter comprises a region with an angle, curve or
bend.
87. The system according to claim 86 wherein the angle, curve or
bend can be adjusted.
88. The system according to claim 46 wherein the balloon catheter
comprises a hub with multiple ports.
89. The system according to claim 46 wherein the balloon catheter
comprises a hub with a port selected from the group consisting of
guidewire ports, inflation ports, vacuum ports, flushing ports and
electrical connection ports.
90. The system according to claim 46 wherein the balloon catheter
comprises a hub comprising orientation markers.
91. The system according to claim 46 wherein the balloon catheter
comprises a hub comprising a handle.
92. The system according to claim 46 wherein the balloon catheter
comprises a hub comprising a valve.
93. The system according to claim 46 wherein the balloon catheter
comprises a hub comprising one or more extension tubes.
94. A system for diagnosing and/or treating sinusitis or another
disorder affecting the nose, paranasal sinuses or other anatomical
structures of the ear, nose or throat comprising: an introducing
member comprising a proximal end and a distal end for insertion
into in a nasal cavity; an ostium dilating device that can be
advanced along the introducing member.
95. A system for diagnosing and/or treating sinusitis or another
disorder affecting the nose, paranasal sinuses or other anatomical
structures of the ear, nose or throat comprising: an introducing
member comprising a proximal end and a distal end for insertion
into in a nasal cavity; a working device that can be advanced along
the introducing member wherein the working device comprises a shaft
of a stiffness less than 200 pound-force per inch over a shaft
length of one inch.
96. A system for diagnosing and/or treating sinusitis or another
disorder affecting the nose, paranasal sinuses or other anatomical
structures of the ear, nose or throat comprising: an introducing
member comprising a proximal end and a distal end for insertion
into in a nasal cavity; a working device that can be advanced along
the introducing member wherein the surface of contact between the
introducing member and the working device comprise at least one
lubricious surface.
97. A method for improving drainage from an ethmoid sinus having an
ostium and one or more adjacent ethmoid air cells in a human or
animal subject, said method comprising the steps of: A) inserting a
guide through the ostium and into the ethmoid sinus; B) advancing
an enlarging device over the guide to a position within the ostium
and using that enlarging device to enlarge the ostium; C) advancing
a penetrating device into the ethmoid sinus and using that
penetrating device to form an opening between the ethmod sinus and
an ethmoid air cell; D) advancing a guide from the ethmoid sinus,
through the opening and into the ethmoid air cell; and E) advancing
an enlarging device over the guide of step D to a position within
the opening and using the enlarging device to enlarge the
opening.
98. A method according to claim 97 further comprising the steps of:
F) advancing a penetrating device over the guide and using that
penetrating device to form a second opening between the ethmod air
cell and a second ethmoid air cell; and G) advancing the guide from
the ethmoid air cell, through the second opening and into the
second ethmoid air cell; and H) advancing an enlarging device over
the guide to a position within the second opening and using the
enlarging device to enlarge the second opening.
99. A method according to claim 98 further comprising the steps of:
I) advancing a penetrating device over the guide and using that
penetrating device to form a third opening between the second
ethmod air cell and a third ethmoid air cell; and J) advancing the
guide from the second ethmoid air cell, through the third opening
and into the third ethmoid air cell; and K) advancing an enlarging
device over the guide to a position within the third opening and
using the enlarging device to enlarge the third opening.
100. A method according to claim 97 further comprising the steps
of: I) retracting the guide into the ethmoid sinus; J) advancing a
penetrating device over the guide and using that penetrating device
to form a second opening between the ethmod sinus and a second
ethmoid air cell; and G) advancing the guide from the ethmoid
sinus, through the second opening and into the second ethmoid air
cell; and H) advancing an enlarging device over the guide to a
position within the second opening and using the enlarging device
to enlarge the second opening.
101. A method according to claim 98 further comprising the steps
of: II) retracting the guide into the ethmoid air cell; J)
advancing a penetrating device over the guide and using that
penetrating device to form a third opening between the ethmod air
cell and a third ethmoid air cell; and G) advancing the guide from
the ethmoid sinus, through the third opening and into the third
ethmoid air cell; and H) advancing an enlarging device over the
guide to a position within the third opening and using the
enlarging device to enlarge the third opening.
102. A method according to claim 97 wherein, in Step C, the
penetrating device is advanced over the guide that was used in
Steps A and B.
103. A method according to claim 97 wherein the guide used in Steps
D and E is the same guide that was used in Steps A and B.
104. A method according to claim 97 wherein the guide used in Steps
D and E is different from the guide that was used in Steps A and
B.
105. A method according to claim 97 wherein the guide used in Steps
A and B comprises a guidewire.
106. A method according to claim 97 wherein the guide used in Steps
D and E comprises a guidewire.
107. A method according to claim 97 wherein the enlarging device
used in Step E is the same enlarging device that was used in Step
B.
108. A method according to claim 97 wherein the enlarging device
used in Step E is different from the enlarging device that was used
in Step B.
109. A method according to claim 97 wherein the enlarging device
used in Step B comprises a dilator.
110. A method according to claim 109 wherein the dilator comprises
a balloon.
111. A method according to claim 109 wherein the dilator comprises
at least two sequential dilators of progressively larger
diameter.
112. A method according to claim 109 wherein the dilator comprises
a mechanical dilator having a plurality of struts that are
alternately moveable between a collapsed configuration and an
expanded configuration.
113. A method according to claim 97 wherein the penetrating device
comprises a tubular member that has a penetrating distal tip.
114. A method according to claim 97 wherein the penetrating device
comprises a mechanical boring device.
Description
RELATED APPLICATION
[0001] This application is a continuation-in-part of copending U.S.
patent application Ser. No. 10/829,917 entitled "Devices, Systems
and Methods for Diagnosing and Treating Sinusitis and Other
Disorders of the Ears, Nose and/or Throat" filed on Apr. 21, 2004,
the entire disclosure of which is expressly incorporated herein by
reference.
FIELD OF THE INVENTION
[0002] The present invention relates generally to medical devices
and methods and more particularly to minimally invasive, devices,
systems and methods for treating sinusitis and other ear, nose
& throat disorders.
BACKGROUND
[0003] The nose is responsible for warming, humidifying and
filtering inspired air and for conserving heat and moisture from
expired air. The nose is formed mainly of cartilage, bone, mucous
membranes and skin.
[0004] The bones in the nose contain a series of cavities known as
paranasal sinuses that are connected by passageways. The paranasal
sinuses include frontal sinuses, ethmoid sinuses, sphenoid sinuses
and maxillary sinuses. The paranasal sinuses are lined with
mucous-producing epithelial tissue and ultimately opening into the
nasal cavity. Normally, mucous produced by the epithelial tissue
slowly drains out of each sinus through an opening known as an
ostium. If the epithelial tissue of one of these passageways
becomes inflamed for any reason, the cavities which drain through
that passageway can become blocked. This blockage can be periodic
(resulting in episodes of pain) or chronic. This interference with
drainage of mucous (e.g., occlusion of a sinus ostium) can result
in mucosal congestion within the paranasal sinuses. Chronic mucosal
congestion of the sinuses can cause damage to the epithelium that
lines the sinus with subsequent decreased oxygen tension and
microbial growth (e.g., a sinus infection).
Sinusitis:
[0005] The term "sinusitis" refers generally to any inflammation or
infection of the paranasal sinuses caused by bacteria, viruses,
fungi (molds), allergies or combinations thereof. It has been
estimated that chronic sinusitis (e.g., lasting more than 3 months
or so) results in 18 million to 22 million physician office visits
per year in the United States.
[0006] Patients who suffer from sinusitis typically experience at
least some of the following symptoms: [0007] headaches or facial
pain [0008] nasal congestion or post-nasal drainage [0009]
difficulty breathing through one or both nostrils [0010] bad breath
[0011] pain in the upper teeth Thus, one of the ways to treat
sinusitis is by restoring the lost mucous flow. The initial therapy
is drug therapy using anti-inflammatory agents to reduce the
inflammation and antibiotics to treat the infection. A large number
of patients do not respond to drug therapy. Currently, the gold
standard for patients with chronic sinusitis that do not respond to
drug therapy is a corrective surgery called Functional Endoscopic
Sinus Surgery. Current and Proposed Procedures for Sinus
Treatment
[0012] Functional Endoscopic Sinus Surgery
[0013] In FESS, an endoscope is inserted into the nose and, under
visualization through the endoscope, the surgeon may remove
diseased or hypertrophic tissue or bone and may enlarge the ostia
of the sinuses to restore normal drainage of the sinuses. FESS
procedures are typically performed with the patient under general
anesthesia.
[0014] Although FESS continues to be the gold standard therapy for
surgical treatment of severe sinus disease, FESS does have several
shortcomings. For example, FESS can cause significant
post-operative pain. Also, some FESS procedures are associated with
significant postoperative bleeding and, as a result, nasal packing
is frequently placed in the patient's nose for some period of time
following the surgery. Such nasal packing can be uncomfortable and
can interfere with normal breathing, eating, drinking etc. Also,
some patients remain symptomatic even after multiple FESS
surgeries. Additionally, some FESS procedures are associated with
risks of iatrogenic orbital, intracranial and sinonasal injury.
Many otolaryngologists consider FESS an option only for patients
who suffer from severe sinus disease (e.g., those showing
significant abnormalities under CT scan). Thus, patients with less
severe disease may not be considered candidates for FESS and may be
left with no option but drug therapy. One of the reasons why FESS
procedures can be bloody and painful relates to the fact that
instruments having straight, rigid shafts are used. In order to
target deep areas of the anatomy with such straight rigid
instrumentation, the physician needs to resect and remove or
otherwise manipulate any anatomical structures that may lie in the
direct path of the instruments, regardless of whether those
anatomical structures are part of the pathology.
[0015] Balloon Dilation Based Sinus Treatment
[0016] Methods and devices for sinus intervention using dilating
balloons have been disclosed in U.S. Pat. No. 2,525,183 (Robison)
and United States Patent Publication No. 2004/0064150 A1 (Becker).
For example, U.S. Pat. No. 2,525,183 (Robison) discloses an
inflatable pressure device which can be inserted following sinus
surgery and inflated within the sinus. The patent does not disclose
device designs and methods for flexibly navigating through the
complex nasal anatomy to access the natural ostia of the sinuses.
The discussion of balloon materials is also fairly limited to thin
flexible materials like rubber which are most likely to be
inadequate for dilating the bony ostia of the sinus.
[0017] United States patent publication No. 2004/0064150 A1
(Becker) discloses balloon catheters formed of a stiff hypotube to
be pushed into a sinus. The balloon catheters have a stiff hypotube
with a fixed pre-set angle that enables them to be pushed into the
sinus. In at least some procedures wherein it is desired to
position the balloon catheter in the ostium of a paranasal sinus,
it is necessary to advance the balloon catheter through complicated
or tortuous anatomy in order to properly position the balloon
catheter within the desired sinus ostium. Also, there is a degree
of individual variation in the intranasal and paranasal anatomy of
human beings, thus making it difficult to design a stiff-shaft
balloon catheter that is optimally shaped for use in all
individuals. Indeed, rigid catheters formed of hypotubes that have
pre-set angles cannot be easily adjusted by the physician to
different shapes to account for individual variations in the
anatomy. In view of this, the Becker patent application describes
the necessity of having available a set of balloon catheters, each
having a particular fixed angle so that the physician can select
the appropriate catheter for the patient's anatomy. The requirement
to test multiple disposable catheters for fit is likely to be very
expensive and impractical. Moreover, if such catheter are
disposable items (e.g., not sterilizable and reusable) the need to
test and discard a number of catheters before finding one that has
the ideal bend angle could be rather expensive.
[0018] Thus, although the prior art discloses the use of dilating
balloons for sinus treatments, it does not disclose the various
means for navigation through the complex anatomy without
significant manipulation of non-pathogenic anatomical regions that
obstruct direct access to the sinus openings. Further, the prior
art only discloses balloons of relatively simple shapes or
materials for dilating sinus openings. Further, this art does not
sufficiently elaborate beyond endoscopy on other means for imaging
or tracking the position of such devices within the sinus
anatomy.
[0019] Thus, there is a need for new devices and methods for easily
navigating the complex anatomy of the nasal cavities and paranasal
sinuses and for treating disorders of the paranasal sinuses with
minimal complications due to individual variations in anatomy and
causing minimal trauma to or disruption of anatomical structures
that are not pathogenic.
SUMMARY OF THE INVENTION
[0020] In general, the present invention provides methods, devices
and systems for diagnosing and/or treating sinusitis or other
conditions of the ear, nose or throat.
[0021] In accordance with the present invention, there are provided
methods wherein one or more flexible or rigid elongate devices as
described herein are inserted in to the nose, nasopharynx,
paranasal sinus, middle ear or associated anatomical passageways to
perform an interventional or surgical procedure. Examples of
procedures that may be performed using these flexible catheters or
other flexible elongate devices include but are not limited to:
remodeling or changing the shape, size or configuration of a sinus
ostium or other anatomical structure that affects drainage from one
or more paranasal sinuses; cutting, ablating, debulking,
cauterizing, heating, freezing, lasing, forming an osteotomy or
trephination in or otherwise modifying bony or cartilaginous tissue
within paranasal sinus or elsewhere within the nose; removing puss
or aberrant matter from the paranasal sinus or elsewhere within the
nose; scraping or otherwise removing cells that line the interior
of a paranasal sinus; delivering contrast medium; delivering a
therapeutically effective amount of a therapeutic substance;
implanting a stent, tissue remodeling device, substance delivery
implant or other therapeutic apparatus; cutting, ablating,
debulking, cauterizing, heating, freezing, lasing, dilating or
otherwise modifying tissue such as nasal polyps, abberant or
enlarged tissue, abnormal tissue, etc.; grafting or implanting
cells or tissue; reducing, setting, screwing, applying adhesive to,
affixing, decompressing or otherwise treating a fracture;
delivering a gene or gene therapy preparation; removing all or a
portion of a tumor; removing a polyp; delivering histamine, an
allergen or another substance that causes secretion of mucous by
tissues within a paranasal sinus to permit assessment of drainage
from the sinus; implanting a cochlear implant or indwelling hearing
aid or amplification device, etc.
[0022] Still further in accordance with the invention, there are
provided devices and systems for performing some or all of the
procedures described herein. Introducing devices may be used to
facilitate insertion of working devices (e.g. catheters e.g.
balloon catheters, tissue cutting or remodeling devices,
guidewires, devices for implanting elements like stents,
electrosurgical devices, energy emitting devices, devices for
delivering diagnostic or therapeutic agents, substance delivery
implants, scopes etc) into the paranasal sinuses and other
structures in the ear, nose or throat.
[0023] Still further in accordance with the invention, there are
provided apparatus and methods for navigation and imaging of the
interventional devices within the sinuses using endoscopic
including stereo endoscopic, fluoroscopic, ultrasonic,
radiofrequency localization, electromagnetic, magnetic and other
radiative energy based modalities. These imaging and navigation
technologies may also be referenced by computer directly or
indirectly to pre-existing or simultaneously created 3-D or 2-D
data sets which help the doctor place the devices within the
appropriate region of the anatomy.
[0024] Further aspects, details and embodiments of the present
invention will be understood by those of skill in the art upon
reading the following detailed description of the invention and the
accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0025] FIG. 1 shows a schematic diagram of a system for
catheter-based minimally invasive sinus surgery of the present
invention being used to perform a sinus surgery procedure on a
human patient.
[0026] FIG. 1A is an enlarged view of portion "1A" of FIG. 1.
[0027] FIGS. 2A through 2D are partial sagittal sectional views
through a human head showing various steps of a method for gaining
access to a paranasal sinus using a guide and thereafter dilating
or remodeling the ostial opening into the paranasal sinus.
[0028] FIGS. 2E through 2H are partial sagittal sectional views
through a human head showing various steps of a method for gaining
access to a paranasal sinus using a steerable guide and
thereafter.
[0029] FIGS. 2I through 2L are partial sagittal sectional views
through a human head showing various steps of a method for gaining
access to a paranasal sinus using an introducing device in the form
of a guidewire with a preset shape.
[0030] FIGS. 2M through 20 are partial sagittal sectional views
through a human head showing various steps of a method for gaining
access to a paranasal sinus using a balloon catheter that has a
guide protruding from its distal end.
[0031] FIGS. 2P through 2X are partial sagittal sectional views
through a human head showing various steps of a method of accessing
an ethmoid sinus through a natural or artificially created opening
of the ethmoid sinus.
[0032] FIGS. 2Y through 2AC are partial coronal sectional views
through a human head showing various steps of a method for treating
a mucocele in a frontal sinus.
[0033] FIGS. 3A through 3C are partial coronal sectional views
through a human head showing various steps of a method of accessing
a paranasal sinus through an artificially created opening of the
paranasal sinus.
[0034] FIG. 4A shows a partial longitudinal sectional view of a
system for dilating a sinus ostium or other intranasal anatomical
structure, such system comprising three progressively larger
dilators useable in sequence.
[0035] FIGS. 4B through 4E show various steps of a method of
dilating a nasal cavity using a working device comprising a balloon
catheter with a pressure-expandable stent.
[0036] FIG. 4F shows a partial perspective view of a working device
that comprises a side suction and/or side cutter.
[0037] FIG. 4G shows a partial perspective view of a working device
that comprises a rotating cutter to cut away tissue.
[0038] FIGS. 4H and 4I show various steps of a method of dilating
the ostium of a paranasal sinus or other nasal passageway using a
mechanical dilator.
[0039] FIGS. 4J and 4K show perspective views of a mechanical
dilator comprising a screw mechanism.
[0040] FIGS. 4L and 4M show sectional views of a mechanical dilator
that comprises a pushable member.
[0041] FIGS. 4N and 4O show sectional views of a mechanical dilator
that comprises a pullable member.
[0042] FIGS. 4P and 4Q show sectional views of a mechanical dilator
that comprises a hinged member.
[0043] FIGS. 4R through 4W are schematic diagrams of alternative
configurations for the distal portions of mechanical dilators of
the types shown in FIGS. 4H through 4Q.
[0044] FIG. 5A shows a perspective view of a balloon that comprises
a conical proximal portion, a conical distal portion and a
cylindrical portion between the conical proximal portion and the
conical distal portion.
[0045] FIG. 5B shows a perspective view of a conical balloon.
[0046] FIG. 5C shows a perspective view of a spherical balloon.
[0047] FIG. 5D shows a perspective view of a conical/square long
balloon.
[0048] FIG. 5E shows a perspective view of a long spherical
balloon.
[0049] FIG. 5F shows a perspective view of a bi-lobed "dog bone"
balloon.
[0050] FIG. 5G shows a perspective view of an offset balloon.
[0051] FIG. 5H shows a perspective view of a square balloon.
[0052] FIG. 5I shows a perspective view of a conical/square
balloon.
[0053] FIG. 5J shows a perspective view of a conical/spherical long
balloon.
[0054] FIG. 5K shows a perspective view of an embodiment of a
tapered balloon.
[0055] FIG. 5L shows a perspective view of a stepped balloon.
[0056] FIG. 5M shows a perspective view of a conical/offset
balloon.
[0057] FIG. 5N shows a perspective view of a curved balloon.
[0058] FIG. 5O shows a partial perspective view of a balloon
catheter device comprising a balloon for delivering diagnostic or
therapeutic substances.
[0059] FIG. 5P shows a partial perspective view of a balloon/cutter
catheter device comprising a balloon with one or more cutter
blades.
[0060] FIGS. 5Q and 5Q' shows a perspective view of a balloon
catheter device comprising a balloon with a reinforcing braid
attached on the external surface of the balloon. FIG. 5Q' shows a
perspective view of a reinforcing braid that can be used with the
balloon catheter device in FIGS. 5Q and 5Q'.
[0061] FIG. 5R shows a partial sectional view of a balloon catheter
wherein inflation ports are located near the distal end of the
balloon.
[0062] FIG. 5S shows a partial sectional view of an embodiment of a
balloon catheter comprising multiple balloons inflated by a single
lumen.
[0063] FIG. 5T shows a partial sectional view of a balloon catheter
comprising multiple balloons inflated by multiple lumens.
[0064] FIGS. 5U through 5AB show perspective and sectional views of
various embodiments of balloon catheters having sensors mounted
thereon or therein.
[0065] FIG. 6A shows a partial perspective view of a shaft design
useable in the various devices disclosed herein, wherein the shaft
comprises an external spiral wire.
[0066] FIG. 6B shows a partial perspective view of a shaft design
for the various devices disclosed herein, wherein the shaft
comprises a stiffening wire.
[0067] FIG. 6C shows a partial perspective view of an embodiment of
a shaft design for the various devices disclosed herein, wherein
the shaft comprises stiffening rings.
[0068] FIG. 6D shows a partial perspective view of a shaft design
for the various devices disclosed herein, wherein the shaft
comprises controllable stiffening elements.
[0069] FIG. 6E shows a partial perspective view of a shaft design
for the various devices disclosed herein, wherein the shaft
comprises a hypotube.
[0070] FIG. 6F shows a partial perspective cut-away view of a shaft
design for the various devices disclosed herein, wherein the shaft
comprises a braid.
[0071] FIG. 6F' is an enlarged side view of the braid of the device
of FIG. 6F.
[0072] FIG. 6G shows a partial perspective view of an embodiment of
a device comprising a shaft having a plastically deformable
region.
[0073] FIG. 6H shows a partial perspective view of a device
comprising a shaft having a flexible element.
[0074] FIG. 6I shows a partial perspective view of a shaft
comprising a malleable element.
[0075] FIG. 6J shows a partial perspective view of the shaft of
FIG. 6I in a bent configuration.
[0076] FIG. 6K shows a cross sectional view through plane 6K-6K of
FIG. 6I.
[0077] FIG. 6L shows a partial sectional view of an embodiment of a
controllably deformable shaft.
[0078] FIG. 6M shows a partial sectional view of the controllably
deformable shaft of FIG. 6L in a deformed state.
[0079] FIG. 6N shows a perspective view of a balloon catheter
comprising a rigid or semi-rigid member.
[0080] FIGS. 6O through 6Q show sectional views of a balloon
catheter that comprises an insertable and removable element.
[0081] FIG. 7A shows a cross sectional view through a balloon
catheter shaft comprising two cylindrical lumens.
[0082] FIG. 7B shows a cross sectional view through a balloon
catheter shaft comprising an inner lumen and an annular outer lumen
disposed about the inner lumen.
[0083] FIG. 7C shows a cross sectional view through a balloon
catheter shaft which comprises a first tubular element with a first
lumen, a second tubular element with a second lumen and a jacket
surrounding the first and second tubular elements.
[0084] FIG. 7D shows a cross sectional view through a balloon
catheter shaft comprising three lumens.
[0085] FIG. 7E shows a cross sectional view through a balloon
catheter shaft comprising a cylindrical element, a tubular element
that has a lumen and a jacket surrounding the cylindrical element
and the tubular element.
[0086] FIG. 7F shows a cross sectional view of through a balloon
catheter shaft comprising an embedded braid.
[0087] FIG. 7G shows a partial perspective view of a catheter shaft
comprising a zipper lumen with a guide extending through a portion
of the zipper lumen.
[0088] FIG. 7H shows a cross sectional view through line 7H-7H of
FIG. 7G.
[0089] FIG. 7I shows is a partial longitudinal sectional view of a
catheter shaft comprising a rapid exchange lumen with a guide
extending through the rapid exchange lumen.
[0090] FIG. 7J shows a cross sectional view of the catheter shaft
of FIG. 7I through line 7J-7J.
[0091] FIG. 7K shows a cross sectional view of the catheter shaft
of FIG. 7I through line 7K-7K.
[0092] FIG. 7L is a partial perspective view of a balloon catheter
device of the present invention comprising a through-lumen and a
balloon inflation lumen within the shaft of the catheter.
[0093] FIG. 7M is a cross sectional view through line 7M-7M of FIG.
7L.
[0094] FIG. 7N is a cross sectional view through line 7N-7N of FIG.
7L.
[0095] FIG. 7O is a partial perspective view of another balloon
catheter device of the present invention comprising a through lumen
within the shaft of the catheter and a balloon inflation tube
disposed next to and optionally attached to the catheter shaft.
[0096] FIG. 7P is a cross sectional view through line 7P-7P of FIG.
7O.
[0097] FIG. 7Q is a cross sectional view through line 7Q-7Q of FIG.
7O.
[0098] FIG. 8A shows a partial perspective view of a catheter shaft
comprising distance markers.
[0099] FIG. 8B shows a partial perspective view of a catheter shaft
comprising one type of radiopaque markers.
[0100] FIG. 8C shows a partial perspective view of a catheter shaft
comprising another type of radiopaque markers.
[0101] FIG. 8D shows a partial perspective view of a balloon
catheter comprising an array of radiopaque markers arranged on the
outer surface of the balloon.
[0102] FIG. 8E shows a partial perspective view of a balloon
catheter comprising an array of radiopaque markers arranged on an
inner surface of the balloon.
[0103] FIG. 8E' is a longitudinal sectional view of FIG. 8E.
DETAILED DESCRIPTION
[0104] The following detailed description, the accompanying
drawings and the above-set-forth Brief Description of the Drawings
are intended to describe some, but not necessarily all, examples or
embodiments of the invention. The contents of this detailed
description do not limit the scope of the invention in any way.
[0105] A number of the drawings in this patent application show
anatomical structures of the ear, nose and throat. In general,
these anatomical structures are labeled with the following
reference letters: TABLE-US-00001 Nasal Cavity NC Nasopharynx NP
Frontal Sinus FS Ethmoid Sinus ES Ethmoid Air Cells EAC Sphenoid
Sinus SS Sphenoid Sinus Ostium SSO Maxillary Sinus MS Mucocele
MC
[0106] FIGS. 1 and 1A provide a general showing of a minimally
invasive surgery system of the present invention comprising a C-arm
fluoroscope 1000 that is useable to visualize a first introducing
device 1002 (e.g., a guide catheter or guide tube), a second
introducing device 1004 (e.g., a guidewire or elongate probe) and a
working device 1006 (e.g., a balloon catheter, other dilation
catheter, debrider, cutter, etc.). FIGS. 2A-8E' show certain
non-limiting examples of the introducing devices 1002 (e.g., a
guide catheter or guide tube), 1004 (guides, guidewires, elongate
probes, etc.) and working devices 1006 (e.g., a balloon catheters,
other dilation catheters, debrider, cutters, etc.) that may be
useable in accordance with this invention. The devices 1002, 1004,
1006 may be radiopaque and/or may incorporate radiopaque markers
such that C-arm fluoroscope 1000 may be used to image and monitor
the positioning of the devices 1002, 1004, 1006 during the
procedure. In addition to or, as an alternative to the use of
radiographic imaging, the devices 1002, 1004, 1006 may incorporate
and/or may be used in conjunction with one or more endoscopic
devices, such as the typical rigid or flexible endoscopes or stereo
endocscopes used by otolaryngologists during FESS procedures. Also,
in addition to or as an alternative to radiographic imaging and/or
endoscopic visualizations, some embodiments of the devices 1002,
1004, 1006 may incorporate sensors which enable the devices 1002,
1004, 1006 to be used in conjunction with image guided surgery
systems or other electro-anatomical mapping/guidance systems
including but not limited to: VectorVision (BrainLAB AG); HipNav
(CASurgica); CBYON Suite (CBYON); InstaTrak, FluoroTrak, ENTrak (GE
Medical); StealthStation Treon, iOn (Medtronic); Medivision;
Navitrack (Orthosoft); OTS (Radionics); VISLAN (Siemens); Stryker
Navigation System (Stryker Leibinger); Voyager, Z-Box (Z-Kat Inc.)
and NOGA and CARTO systems (Johnson & Johnson). Commercially
available interventional navigation systems can also be used in
conjunction with the devices and methods. Further non-fluoroscopic
interventional imaging technologies including but not limited to:
OrthoPilot (B. Braun Aesculap); PoleStar (Odin Medical
Technologies; marketed by Medtronic); SonoDoppler, SonoWand
(MISON); CT Guide, US Guide (UltraGuide) etc. may also be used in
conjunction with the devices and methods. Guidance under magnetic
resonance is also feasible if the catheter is modified to interact
with the system appropriately.
[0107] It is to be appreciated that the devices and methods of the
present invention relate to the accessing and dilation or
modification of sinus ostia or other passageways within the ear
nose and throat. These devices and methods may be used alone or may
be used in conjunction with other surgical or non-surgical
treatments, including but not limited to the delivery or
implantation of devices and drugs or other substances as described
in copending U.S. patent application Ser. No. 10/912,578 entitled
Implantable Devices and Methods for Delivering Drugs and Other
Substances to Treat Sinusitis and Other Disorders filed on Aug. 4,
2004, the entire disclosure of which is expressly incorporated
herein by reference.
[0108] FIGS. 2A through 2D are partial sagittal sectional views
through a human head showing various steps of a method of gaining
access to a paranasal sinus using a guide catheter. In FIG. 2A, a
first introducing device in the form of a guide catheter 200 is
introduced through a nostril and through a nasal cavity NC to a
location close to an ostium SSO of a sphenoid sinus SS. The guide
catheter 200 may be flexible. Flexible devices are defined as
devices with a flexural stiffness less than about 200 pound-force
per inch over a device length of one inch. The guide catheter 200
may be straight or it may incorporate one or more preformed curves
or bends. In embodiments where the guide catheter 200 is curved or
bent, the deflection angle of the curve or bend may be in the range
of up to 135.degree.. Examples of specific deflection angles formed
by the curved or bent regions of the guide catheter 200 are
0.degree., 30.degree., 45.degree., 60.degree., 70.degree.,
90.degree., 120.degree. and 135.degree.. Guide catheter 200 can be
constructed from suitable elements like Pebax, Polyimide, Braided
Polyimide, Polyurethane, Nylon, PVC, Hytrel, HDPE, PEEK, metals
like stainless steel and fluoropolymers like PTFE, PFA, FEP and
EPTFE. Guide catheter 200 can have a variety of surface coatings
e.g. hydrophilic lubricious coatings, hydrophobic lubricious
coatings, abrasion resisting coatings, puncture resisting coatings,
electrically or thermal conductive coatings, radiopaque coatings,
echogenic coatings, thrombogenicity reducing coatings and coatings
that release drugs. In FIG. 2B, a second introduction device
comprising a guidewire 202 is introduced through the first
introduction device (i.e., the guide catheter 200) so that the
guidewire 202 enters the sphenoid sinus SS through the ostium SSO.
Guidewire 202 may be constructed and coated as is common in the art
of cardiology. In FIG. 2C, a working device 204 for example a
balloon catheter is introduced over guidewire 202 into the sphenoid
sinus SS. Thereafter, in FIG. 2D, the working device 204 is used to
perform a diagnostic or therapeutic procedure. In this particular
example, the procedure is dilation of the sphenoid sinus ostium
SSO, as is evident from FIG. 2D. However, it will be appreciated
that the present invention may also be used to dilate or modify any
sinus ostium or other man-made or naturally occurring anatomical
opening or passageway within the nose, paranasal sinuses,
nasopharynx or adjacent areas. After the completion of the
procedure, guide catheter 200, guidewire 202 and working device 204
are withdrawn and removed. As will be appreciated by those of skill
in the art, in this or any of the procedures described in this
patent application, the operator may additionally advance other
types of catheters or of the present invention, a guidewire 202 may
be steerable (e.g. torquable, actively deformable) or shapeable or
malleable. Guidewire 202 may comprise an embedded endoscope or
other navigation or imaging modalities including but not limited to
fluoroscopic, X-ray radiographic, ultrasonic, radiofrequency
localization, electromagnetic, magnetic, robotic and other
radiative energy based modalities. In this regard, some of the
figures show optional scopes SC is dotted lines. It is to be
appreciated that such optional scopes SC may comprise any suitable
types of rigid or flexible endoscopes and such optional scopes SC
may be separate from or incorporated into the working devices
and/or introduction devices of the present invention.
[0109] FIGS. 2E through 2H are partial sagittal sectional views
through a human head showing various steps of a method of gaining
access to a paranasal sinus using a steerable catheter. In FIG. 2E,
an introducing device in the form of a steerable catheter 206 is
introduced through a nostril. Although commercially available
devices are neither designed, nor easily usable for this technique
in the sinuses, examples of a device which has a steerable tip with
functionality similar to that described here include but are not
limited to the Naviport.TM. manufactured by Cardima, Inc. in
Fremont, Calif.; Attain Prevail and Attain Deflectable catheters
manufactured by Medtronic; Livewire Steerable Catheters
manufactured by St. Jude Medical Inc.; Inquiry.TM. Steerable
Diagnostic Catheters manufactured by Boston Scientific;
TargetCath.TM. manufactured by EBI; Safe-Steer Catheter
manufactured by Intraluminal Therapeutics, Inc.; Cynosar
manufactured by Catheter Research, Inc.; Torque Control Balloon
Catheter manufactured by Cordis Corp. and DynamicDeca Steerable
Catheter and Dynamic XT Steerable Catheter manufactured by A.M.I.
Technologies Ltd, Israel. Steerable catheter 206 comprises a
proximal portion, a distal portion and a controllably deformable
region between the proximal portion and the distal portion. In FIG.
2F, the steerable catheter 206 is steered through the nasal anatomy
so that the distal portion of steerable catheter 206 is near an
ostium SSO of a sphenoid sinus SS. In FIG. 2G, a working device in
the form of a balloon catheter 208 is introduced through steerable
catheter 206 so that it enters sphenoid sinus SS through the ostium
SSO. Thereafter, balloon catheter 208 is adjusted so that the
balloon of the balloon catheter is located in the ostium SSO. In
FIG. 2H, balloon catheter 208 is used to dilate the ostium SSO.
After completion of the procedure, steerable catheter 206 and
balloon catheter 208 are withdrawn from the nasal anatomy. In this
example, only a first introduction device in the form of a
steerable catheter 206 is used to effect insertion and operative
positioning of the working device (which in this example is balloon
catheter 208). It will be appreciated, however, in some procedures,
a second introduction device (e.g., an elongate guide member,
guidewire, elongate probe, etc.) could be advanced through the
lumen of the steerable catheter 206 and the working device 208
could then be advanced over such second introduction device to the
desired operative location.
[0110] FIGS. 2I through 2L are partial sagittal sectional views
through a human head showing various steps of a method for gaining
access to a paranasal sinus using an introducing device in the form
of a guidewire with a preset shape. In FIG. 2I, an introducing
device in the form of a guidewire 210 with a preset shape is
introduced in a nasal cavity. Guidewire 210 comprises a proximal
portion and a distal portion and is shaped such that it can easily
navigate through the nasal anatomy. In one embodiment, guidewire
210 is substantially straight. In another embodiment, guidewire 210
comprises an angled, curved or bent region between the proximal
portion and the distal portion. Examples of the deflection angle of
the angled, curved or bent regions are 0.degree., 30.degree.,
45.degree., 60.degree., 70.degree., 90.degree., 120.degree. and
135.degree.. In FIG. 2J, guidewire 210 is advanced through the
nasal anatomy so that the distal tip of guidewire enters a sphenoid
sinus SS through an ostium SSO. In FIG. 2K, a working device in the
form of a balloon catheter 212 is advanced along guidewire 210 into
the sphenoid sinus SS. Typically, as described more fully
herebelow, the working device will have a guidewire lumen extending
through or formed in or on at least a portion of the working device
212 to facilitate advancement of the working device 212 over the
guidewire 212 in the manner well understood in the art of
interventional medicine. Thereafter, the position of balloon
catheter 212 is adjusted so that the balloon of the balloon
catheter is located in the ostium SSO. As described elsewhere in
this application, the balloon catheter 212 may be radiopaque and/or
may incorporate one or more visible or imageable markers or
sensors. In FIG. 2L, balloon catheter 212 is used to dilate the
ostium SSO. After completion of the procedure, guidewire 210 and
balloon catheter 212 are withdrawn from the nasal anatomy. In one
embodiment, balloon catheter 212 is shapeable or malleable.
[0111] FIGS. 2M through 2O are partial sagittal sectional views
through a human head showing various steps of a method of gaining
access to a paranasal sinus using a balloon catheter comprising a
steering wire at its distal end. In FIG. 2M, a working device
comprising a balloon catheter 214 comprising a proximal portion and
distal portion is introduced in a nasal cavity. Balloon catheter
214 comprises a steering wire 216 at its distal end. In FIG. 2N,
balloon catheter 214 is advanced through the nasal anatomy into a
sphenoid sinus SS through a sphenoid sinus ostium SSO. Thereafter,
the position of balloon catheter 214 is adjusted so that the
balloon of the balloon catheter is located in the ostium SSO. In
FIG. 20, balloon catheter 214 is used to dilate the ostium SSO.
After completion of the procedure, balloon catheter 214 is
withdrawn from the nasal anatomy. In one embodiment, steering wire
216 can be retracted into or advanced from balloon catheter 214.
The retraction or advancement of steering wire can be controlled by
several means like a thumb wheel, a slide, a button hooked up to
electronic motor and a trigger. In another embodiment, steering
wire 216 may be hollow or may incorporate one or more lumen(s) to
enable it to introduce or remove devices or diagnostic or
therapeutic agents, examples of which are described in copending
U.S. patent application Ser. No. 10/912,578 entitled Implantable
Devices and Methods for Delivering Drugs and Other Substances to
Treat Sinusitis and Other Disorders filed on Aug. 4, 2004, the
entire disclosure of which is expressly incorporated herein by
reference.
[0112] FIGS. 2P through 2X are partial sagittal sectional views
through a human head showing various steps of a method for
accessing an ethmoid sinus through a natural or artificially
created opening of the ethmoid sinus. In FIG. 2P, an introducing
device in the form of a guide catheter 218 is introduced in an
ethmoid sinus ES. Ethmoid sinus ES comprises multiple ethmoid air
cells EAC. In FIG. 2Q, a guidewire 220 is introduced through guide
catheter into a first EAC. Thereafter, in FIG. 2R, a balloon
catheter 222 is introduced over guidewire 220 into the first EAC.
In FIG. 2S, balloon catheter 222 is inflated to dilate the
structures of ES. In FIG. 2T, guide catheter 218, guidewire 220 and
balloon catheter 222 are withdrawn leaving a first new passage in
the ES. The newly created passage in the ES facilitates drainage of
the mucous through the ES. Alternatively, in FIG. 2U, only balloon
catheter 222 is withdrawn. The position of guide catheter 218 is
adjusted and guidewire 220 is introduced into a second EAC. In FIG.
2V, balloon catheter 222 is introduced over guidewire 220 into the
second EAC. In FIG. 2W, balloon catheter 222 is inflated to dilate
the structures of ES. In FIG. 2X, guide catheter 218, guidewire 220
and balloon catheter 222 are withdrawn leaving a second new passage
in the ES. The second new passage in the ES further facilitates
drainage of the mucous through the ES. This method of dilating the
structures of ES can be repeated to create multiple new passages in
the ES.
[0113] FIGS. 2Y through 2AC are partial coronal sectional views
through a human head showing various steps of a method for treating
a mucocele in a frontal sinus. In FIG. 2Y, an introducing device in
the form of a guide catheter 224 is introduced in a frontal sinus
FS through the nasal cavity NC. Frontal sinus FS has a mucocele MC
to be treated. In FIG. 2Z, a penetrating device 226 comprising a
sharp tip 228 is introduced through guide catheter 224 such that
penetrating device 226 punctures the MC at least partially. In FIG.
2M, a balloon catheter 230 is introduced over penetrating device
226 into the MC. Thereafter, in FIG. 2AB, balloon catheter 230 is
inflated to rupture the MC and allow the drainage of contents of
the MC. In FIG. 2AC, penetrating device 226 and balloon catheter
230 are withdrawn.
[0114] The methods disclosed herein may also comprise the step of
cleaning or lavaging anatomy within the nose, paranasal sinus,
nasopharynx or nearby structures including but not limited to
irrigating and suctioning. The step of cleaning the target anatomy
can be performed before or after a diagnostic or therapeutic
procedure.
[0115] The methods of the present invention may also include one or
more preparatory steps for preparing the nose, paranasal sinus,
nasopharynx or nearby structures for the procedure, such as
spraying or ravaging with a vasoconstricting agent (e.g.,
0.025-0.5% phenylephyrine or Oxymetazoline hydrochloride
(Neosynephrine or Afrin) to cause shrinkage of the nasal tissues,
an antibacterial agent (e.g., provodine iodine (Betadine), etc. to
cleanse the tissues, etc.
[0116] FIGS. 3A through 3C are partial coronal sectional views
through a human head showing various steps of a method of accessing
a paranasal sinus through an artificially created opening of the
paranasal sinus. In FIG. 3A, a puncturing device 300 is inserted
through a nostril and used to create an artificial opening in a
maxillary sinus. There are several puncturing devices well known in
the art like needles including needles, needles with bent shafts,
dissectors, punches, drills, corers, scalpels, burs, scissors,
forceps and cutters. In FIG. 3B, puncturing device 300 is withdrawn
and a working device for example a balloon catheter 302 is
introduced through the artificial opening into the maxillary sinus.
In FIG. 3C, balloon catheter 302 is used to dilate the artificially
created opening in the maxillary sinus. After this step, the
balloon catheter 302 is withdrawn. It will be appreciated that, in
some embodiments, the puncturing device 300 may have a lumen
through which an introduction device (e.g., a guidewire or other
elongate probe or member), may be inserted into the maxillary sinus
and the puncturing device 300 may then be removed leaving such
introduction device (e.g., a guidewire or other elongate probe or
member) in place. In such cases, the working device (e.g., balloon
catheter 302) may incorporate a lumen or other structure that
allows the working device (e.g., balloon catheter 300) to be
advanced over the previously inserted introduction device (e.g., a
guidewire or other elongate probe or member).
[0117] In the methods illustrated so far, balloon catheters were
used only as an example for the several alternate working devices
that could be used with this invention. FIG. 4A shows a sectional
view of an example of a working device comprising a set of three
sequential dilators: a first sequential dilator 402, a second
sequential dilator 404 and a third sequential dilator 406. The
D.sub.3 of third sequential dilator 406 is greater than the
diameter D.sub.2 of second sequential dilator 404 which in turn is
greater than the diameter D.sub.1 of first sequential dilator 402.
The sequential dilators may comprise one or more bent or angled
regions. The sequential dilators can be constructed from a variety
of biocompatible materials like stainless steel 316. A variety of
other metals, polymers and materials can also be used to construct
the sequential dilators.
[0118] FIGS. 4B through 4E show various steps of a method of
dilating a nasal cavity using a working device comprising a balloon
catheter with a pressure-expandable stent. In FIG. 4B, an
introducing device e.g. a guidewire 416 is introduced into a nasal
cavity e.g. an ostium of a sinus. In FIG. 4C, a balloon catheter
418 is introduced over guidewire 416 into the nasal cavity. Balloon
catheter 418 comprises a pressure-expandable stent 420. The
position of balloon catheter 418 is adjusted so that
pressure-expandable stent 420 is located substantially within the
target anatomy where the stent is to be deployed. In FIG. 4D, the
balloon of balloon catheter 418 is expanded to deploy
pressure-expandable stent 420. In FIG. 4E, balloon catheter 418 is
withdrawn leaving pressure-expandable stent 420 in the nasal
cavity. Several types of stent designs can be used to construct
stent 420 like metallic tube designs, polymeric tube designs,
chain-linked designs, spiral designs, rolled sheet designs, single
wire designs etc. These designs may have an open celled or closed
celled structure. A variety of fabrication methods can be used for
fabricating stent 420 including but not limited to laser cutting a
metal or polymer element, welding metal elements etc. A variety of
materials can be used for fabricating stent 420 including but not
limited to metals, polymers, foam type materials, plastically
deformable materials, super elastic materials etc. Some
non-limiting examples of materials that can be used to construct
the stent are silicones e.g. silastic, polyurethane, gelfilm and
polyethylene. A variety of features can be added to stent 420
including but not limited to radiopaque coatings, drug elution
mechanisms etc.
[0119] FIG. 4F shows a partial perspective view of an embodiment of
a working device comprising a side suction and/or cutting device
422 comprising a device body 424 having a side opening 426. Cutting
device 422 is advanced into a passageway such as a nostril, nasal
cavity, meatus, ostium, interior of a sinus, etc. and positioned so
that side opening 426 is adjacent to matter (e.g., a polyp, lesion,
piece of debris, tissue, blood clot, etc.) that is to be removed.
Cutting device 422 is rotated to cut tissue that has been
positioned in the side opening 426. Cutting device 422 may
incorporate a deflectable tip or a curved distal end which may
force side opening 426 against the tissue of interest. Further,
this cutting device 422 may have an optional stabilizing balloon
incorporated on one side of cutting device 422 to press it against
the tissue of interest and may also contain one or more on-board
imaging modalities such as ultrasound, fiber or digital optics,
OCT, RF or electromagnetic sensors or emitters, etc.
[0120] FIG. 4G shows a partial perspective view of an embodiment of
a working device comprising a rotating cutter device to cut away
tissue. Rotating cutter device 428 comprises a rotating member 430
enclosed in an introducing device 432. Rotating member 430
comprises a rotating blade 434 located near the distal region of
rotating member 430. Rotating blade 434 may be retractable into
rotating member 430. Rotating cutter device 428 is inserted in a
passageway 436 such as a nostril, nasal cavity, meatus, ostium,
interior of a sinus, etc. and positioned so that rotating blade 434
is adjacent to matter (e.g., a polyp, lesion, piece of debris,
tissue, blood clot, etc.) that is to be removed. Thereafter,
rotating member 430 is rotated to cause rotating blade 434 to
remove tissue. In one embodiment, rotating member 430 can be
retracted into introducing device 432. In another embodiment,
rotating cutter device 428 may comprise a mechanism for suction or
irrigation near the distal end of rotating cutter device 428.
[0121] FIGS. 4H and 4I show various steps of a method of dilating a
nasal cavity using a working device comprising a mechanical dilator
408. Mechanical dilator 408 comprises an outer member 410, an inner
member 412 and one or more elongate bendable members 414. Inner
member 412 can slide within outer member 410. The proximal ends of
bendable members 414 are attached to distal end of outer member 410
and the distal ends of bendable members 414 are attached to distal
end of inner member 412. In FIG. 4H, mechanical dilator 408 is
inserted into an opening in the nasal anatomy e.g. an ostium of a
sinus. Mechanical dilator 408 is positioned in the opening such
that bendable members 414 are within the opening in the nasal
anatomy. In FIG. 41, relative motion of outer member 410 and inner
member 412 causes the distal end of outer member 410 to come closer
to the distal end of inner member 412. This causes bendable members
414 to bend such that the diameter of the distal region of
mechanical dilator 408 increases. This causes bendable members 414
to come into contact with the opening in the nasal anatomy and
exert an outward pressure to dilate the opening. Various components
of mechanical dilator 408 like outer member 410, inner member 412
and bendable members 414 can be constructed from suitable
biocompatible materials like stainless steel 316. A variety of
other metals, polymers and materials can also be used to construct
the various components of mechanical dilator 408. In one
embodiment, outer member 410 is substantially rigid and inner
member 412 is flexible. Outer member 410 can be substantially
straight or may comprise one or more bent or angled regions. Inner
member 412 may comprise one or more lumens.
[0122] FIGS. 4J and 4K illustrate a perspective view of a design of
a mechanical dilator comprising a screw mechanism. FIG. 4J shows
the mechanical dilator comprising an outer member 438 and an inner
screw member 440. Inner screw member 440 is connected to outer
member 438 through a first pivot 442 located on the distal end of
outer member 438. The distal end of inner screw member 440 is
connected to a second pivot 444. The mechanical dilator further
comprises one or more bendable members 446. The distal end of
bendable members 446 is attached to second pivot 444 and the
proximal end of bendable members 446 is attached to fist pivot 442.
In FIG. 4K, inner screw member 440 is rotated in one direction.
This causes second pivot 444 to come closer to first pivot 442.
This causes bendable members 446 to bend in the radial direction
exerting an outward radial force. This force can be used to dilate
or displace portions of the anatomy. Outer member 438 can be
substantially straight or may comprise one or more bent or angled
regions. Inner screw member 440 may comprise one or more
lumens.
[0123] FIGS. 4L and 4M illustrate sectional views of a design of a
mechanical dilator comprising a pushable member. FIG. 4L shows the
mechanical dilator comprising an outer member 448 comprising one or
more bendable regions 449 on the distal end of outer member 448.
Mechanical dilator further comprises an inner pushable member 450
comprising an enlarged region 452 on the distal end of inner
pushable member 450. In FIG. 4M, inner pushable member 450 is
pushed in the distal direction. This exerts an outward force on
bendable regions 449 causing bendable regions 449 to bend in a
radial direction exerting an outward force. This force can be used
to dilate or displace portions of the anatomy. Outer member 448 can
be substantially straight or may comprise one or more bent or
angled regions. Inner pushable member 450 may comprise one or more
lumens.
[0124] FIGS. 4N and 4O illustrate sectional views of a design of a
mechanical dilator comprising a pullable member. FIG. 4N shows the
mechanical dilator comprising an outer member 454 comprising one or
more bendable regions 456 on the distal end of outer member 454.
Mechanical dilator further comprises an inner pullable member 458
comprising an enlarged region 460 on the distal end of inner
pullable member 458. In FIG. 4O, inner pullable member 458 is
pulled in the proximal direction. This exerts an outward force on
bendable regions 456 causing bendable regions 456 to bend in a
radial direction exerting an outward force. This force can be used
to dilate or displace portions of the anatomy. Outer member 454 can
be substantially straight or may comprise one or more bent or
angled regions. Inner pullable member 458 may comprise one or more
lumens.
[0125] FIGS. 4P and 4Q illustrate sectional views of a design of a
mechanical dilator comprising a hinged member. FIG. 4P shows the
mechanical dilator comprising an outer member 462 comprising one or
more bendable regions 464 located on the distal end of outer member
462. The mechanical dilator also comprises an inner member 466
located within outer member 462. In one embodiment, inner member
466 is tubular. The distal end of inner member 466 comprises one or
more first hinges 468. First hinges 468 are hinged to the proximal
ends of one or more moving elements 470. Distal ends of moving
elements 470 are hinged to one or more second hinges 472 located on
the inner surface of outer member 462. In FIG. 4Q, inner member 466
is pushed in the distal direction. This causes moving elements 470
to exert an outward radial force on bendable regions 464 causing
bendable regions 464 to bend in an outward radial direction with an
outward force. This outward force can be used to dilate or displace
portions of the anatomy. Outer member 462 can be substantially
straight or may comprise one or more bent or angled regions. Inner
member 466 may comprise one or more lumens.
[0126] FIGS. 4R through 4W illustrate examples of configurations of
mechanical dilators in FIGS. 4H through 4Q. FIG. 4R shows a
sectional view of a mechanical dilator comprising an inner member
474, an outer stationary member 476 and an outer bendable member
478. In FIG. 4S, movement of inner member 474 displaces outer
bendable member 478 in the radial direction with a force. This
force can be used to dilate or displace portions of the anatomy.
This configuration is useful to exert force in a particular radial
direction. FIG. 4S' shows a partial perspective view of the outer
stationary member 476 of FIG. 4R. FIG. 4T shows a sectional view of
a mechanical dilator comprising an inner member 480, a first outer
hemi-tubular member 482 and a second outer hemi-tubular member 484.
In FIG. 4U, movement of inner member 480 displaces first outer
hemi-tubular member 482 and second outer hemi-tubular member 484 in
the radial direction with a force. This force can be used to dilate
or displace portions of the anatomy. This configuration is useful
to exert force in two diametrically opposite regions. FIG. 4U'
shows a partial perspective view of the first outer hemi-tubular
member 482 and the second outer hemi-tubular member 484 of FIG. 4T.
FIG. 4V shows a sectional view of a mechanical dilator comprising
an inner member 486, a first outer curved member 488 and a second
outer curved member 490. In FIG. 4W, movement of inner member 486
displaces first outer curved member 488 and second outer curved
member 490 in the radial direction with a force. This force can be
used to dilate or displace portions of the anatomy. This
configuration is useful to exert force over smaller areas in two
diametrically opposite regions. FIG. 4W' shows a partial
perspective view of the first outer curved member 488 and the
second outer curved member 490 of FIG. 4V. Similar designs for
mechanical dilators in FIGS. 4H through 4Q are possible using three
or more displaceable members. The inner member in the mechanical
dilators disclosed herein may be replaced by a balloon for
displacing the outer members to exert an outward radial force.
[0127] Several other designs of the working device may also be used
including but not limited to cutters, chompers, rotating drills,
rotating blades, tapered dilators, punches, dissectors, burs,
non-inflating mechanically expandable members, high frequency
mechanical vibrators, radiofrequency ablation devices, microwave
ablation devices, laser devices (e.g. CO2, Argon, potassium titanyl
phosphate, Holmium:YAG and Nd:YAG laser devices), snares, biopsy
tools, scopes and devices that introduce diagnostic or therapeutic
agents.
[0128] FIG. 5A shows a perspective view of an embodiment of a
balloon comprising a conical proximal portion, a conical distal
portion and a cylindrical portion between the conical proximal
portion and the conical distal portion. FIGS. 5B to 5N show
perspective views of several alternate embodiments of the balloon.
FIG. 5B shows a conical balloon, FIG. 5C shows a spherical balloon,
FIG. 5D shows a conical/square long balloon, FIG. 5E shows a long
spherical balloon, FIG. 5F shows a dog bone balloon, FIG. 5G shows
a offset balloon, FIG. 5H shows a square balloon, FIG. 5I shows a
conical/square balloon, FIG. 5J shows a conical/spherical long
balloon, FIG. 5K shows a tapered balloon, FIG. 5L shows a stepped
balloon, FIG. 5M shows a conical/offset balloon and FIG. 5N shows a
curved balloon.
[0129] The balloons disclosed herein can be fabricated from
biocompatible materials including but not limited to polyethylene
terephthalate, Nylon, polyurethane, polyvinyl chloride, crosslinked
polyethylene, polyolefins, HPTFE, HPE, HDPE, LDPE, EPTFE, block
copolymers, latex and silicone. The balloons disclosed herein can
be fabricated by a variety of fabrication methods including but not
limited to molding, blow molding, dipping, extruding etc.
[0130] The balloons disclosed herein can be inflated with a variety
of inflation media including but not limited to saline, water, air,
radiographic contrast materials, diagnostic or therapeutic
substances, ultrasound echogenic materials and fluids that conduct
heat, cold or electricity.
[0131] The balloons in this invention can also be modified to
deliver diagnostic or therapeutic substances to the target anatomy.
For example, FIG. 50 shows a partial perspective view of an
embodiment of a balloon catheter device 500 comprising a balloon
for delivering diagnostic or therapeutic substances. Balloon
catheter device 500 comprises a flexible catheter 502 having a
balloon 504 thereon. The catheter device 500 is advanced, with
balloon 504 deflated, into a passageway such as a nostril, nasal
cavity, meatus, ostium, interior of a sinus, etc. and positioned
with the deflated balloon 504 situated within an ostium, passageway
or adjacent to tissue or matter that is to be dilated, expanded or
compressed (e.g., to apply pressure for hemostasis, etc.).
Thereafter, the balloon 504 may be inflated to dilate, expand or
compress the ostium, passageway, tissue or matter. Thereafter the
balloon 504 may be deflated and the device 500 may be removed. This
balloon 504 may also be coated, impregnated or otherwise provided
with a medicament or substance that will elute from the balloon
into the adjacent tissue (e.g., bathing the adjacent tissue with
drug or radiating the tissue with thermal or other energy to shrink
the tissues in contact with the balloon 504). Alternatively, in
some embodiments, the balloon may have a plurality of apertures or
openings through which a substance may be delivered, sometimes
under pressure, to cause the substance to bathe or diffuse into the
tissues adjacent to the balloon. Alternatively, in some
embodiments, radioactive seeds, threads, ribbons, gas or liquid,
etc. may be advanced into the catheter shaft 502 or balloon 504 or
a completely separate catheter body for some period of time to
expose the adjacent tissue and to achieve a desired diagnostic or
therapeutic effect (e.g. tissue shrinkage, etc.).
[0132] The balloons in this invention can have a variety of surface
features to enhance the diagnostic or therapeutic effects of a
procedure. For example, FIG. 5P shows a partial perspective view of
an embodiment of a balloon/cutter catheter device 506 comprising a
flexible catheter 508 having a balloon 510 with one or more cutter
blades 512 formed thereon. The device 506 is advanced, with balloon
510 deflated, into a passageway such as a nostril, nasal cavity,
meatus, ostium, interior of a sinus, etc. and positioned with the
deflated balloon 510 situated within an ostium, passageway or
adjacent to tissue or matter that is to be dilated, expanded or
compressed and in which it is desired to make one or more cuts or
scores (e.g. to control the fracturing of tissue during expansion
and minimize tissue trauma etc.). Thereafter, the balloon 510 is
inflated to dilate, expand or compress the ostium, passageway,
tissue or matter and causing the cutter blade(s) 512 to make cut(s)
in the adjacent tissue or matter. Thereafter the balloon 510 is
deflated and the device 506 is removed. The blade may be energized
with mono or bi-polar RF energy or otherwise heated such that it
will cut the tissues while also causing hemostasis and/or to cause
thermal contraction of collagen fibers or other connective tissue
proteins, remodeling or softening of cartilage, etc.
[0133] The balloons in this invention can have a variety of
reinforcing means to enhance the balloon properties. For example,
FIGS. 5Q and 5Q' show perspective views of an embodiment of a
balloon catheter device 514 comprising a flexible catheter 516
having a balloon 518 with one or more reinforcing means 520
thereon. In this example, reinforcing means 520 is a braid attached
on the external surface of balloon 518. The reinforcing braid can
be constructed from suitable materials like polymer filaments (e.g.
PET or Kevlar filaments), metallic filaments (e.g. SS316 or Nitinol
filaments) and metallic or non-metallic meshes or sheets. A variety
of other reinforcing means can be used including but not limited to
reinforcing coatings, external or internal reinforcing coils,
reinforcing fabric, reinforcing meshes and reinforcing wires,
reinforcing rings, filaments embedded in balloon materials etc.
FIG. 5Q'' shows a perspective view of a reinforcing braid that can
be used with the balloon catheter device in FIGS. 5Q and 5Q'.
[0134] The balloons in this invention can have a variety of
inflation means to enhance the balloon properties. FIG. 5R shows a
partial sectional view of an embodiment of a balloon catheter 522
comprising a shaft 524 and a balloon 526. Shaft 524 comprises a
balloon inflation lumen. The distal portion of balloon inflation
lumen terminates in inflation ports 528 located near the distal end
of balloon 526. Thus, when balloon catheter 522 is inserted in an
orifice and balloon 526 is inflated, the distal portion of balloon
526 inflates earlier than the proximal portion of balloon 526. This
prevents balloon 526 from slipping back out of the orifice.
[0135] FIGS. 5S through 5T illustrate designs of balloon catheters
comprising multiple balloons. FIG. 5S shows a partial sectional
view of an embodiment of a balloon catheter 530 comprising a shaft
532 with a lumen 533. Lumen 533 opens into three orifices located
on shaft 532 namely a first orifice 534, a second orifice 536 and a
third orifice 538. The three orifices are used to inflate three
balloons. First orifice 534 inflates a first balloon 540, second
orifice 536 inflates a second balloon 542 and third orifice 538
inflates third balloon 544. In one embodiment, first balloon 540
and third balloon 544 are inflated with a single lumen and second
balloon 542 is inflated with a different lumen. In another
embodiment, first balloon 540, second balloon 542 and third balloon
544 interconnected and are inflated with a single lumen. A valve
mechanism allows first balloon and second balloon to inflate before
allowing second balloon to inflate.
[0136] Alternatively, the balloons can be inflated by separate
lumens. FIG. 5T shows a partial sectional view of an embodiment of
a balloon catheter 546 comprising a shaft 548 comprising a first
inflation lumen 550, a second inflation lumen 552 and a third
inflation lumen 554. The three inflation lumens are used to inflate
three non-connected balloons. First inflation lumen 550 inflates a
first balloon 556, second inflation lumen 552 inflates a second
balloon 558 and third inflation lumen 554 inflates a third balloon
560.
[0137] The devices disclosed herein may comprise one or more
navigation or visualization modalities. FIGS. 5U through 5AB
illustrate perspective and sectional views of various embodiments
of a balloon catheter comprising sensors. FIG. 5U shows a partial
perspective view of a balloon catheter comprising an outer member
562, an inner member 564 and a balloon 566 attached to distal
region of outer member 562 and distal region of inner member 564.
The balloon catheter further comprises a first sensor 568 located
on the distal region of outer member 562 and a second sensor 570
located on the distal region of inner member 564. FIG. 5V shows a
crossection through plane 5V-5V in FIG. 5U. Outer member 562
comprises a first sensor lumen 572 to receive the lead from first
sensor 568. Inner member 564 comprises a second sensor lumen 574 to
receive the lead from second sensor 570. Inner member 564 further
comprises a circular lumen 576. Outer member 562 and inner member
564 enclose an annular lumen 578. In one embodiment, annular lumen
578 is a balloon inflation lumen.
[0138] FIG. 5W shows a partial perspective view of a balloon
catheter comprising an outer member 580, an inner member 582 and a
balloon 584 attached to distal region of outer member 580 and
distal region of inner member 582. The balloon catheter further
comprises a first sensor 586 located on the distal region of inner
member 582 and a second sensor 588 located on the distal region of
inner member 582 distal to first sensor 586. FIG. 5X shows a cross
section through plane 5X-5X in FIG. 5W. Inner member 582 comprises
a first sensor lumen 590 to receive the lead from first sensor 586
and a second sensor lumen 592 to receive the lead from second
sensor 588. Inner member 582 further comprises a circular lumen
594. Outer member 580 and inner member 582 enclose an annular lumen
596. In one embodiment, annular lumen 596 is a balloon inflation
lumen.
[0139] FIG. 5Y shows a partial perspective view of a balloon
catheter comprising an outer member 598, an inner member 600 and a
balloon 602 attached to distal region of outer member 598 and
distal region of inner member 600. The balloon catheter further
comprises a first sensor 604 located on the distal region of outer
member 598 and a second sensor 606 located on the distal region of
outer member 598 distal to first sensor 604. FIG. 5Z shows a cross
section through plane 5Z-5Z in FIG. 5Y. Outer member 598 comprises
a first sensor lumen 608 to receive the lead from first sensor 604
and a second sensor lumen 610 to receive the lead from second
sensor 606. Inner member 600 comprises a circular lumen 612. Outer
member 598 and inner member 600 enclose an annular lumen 614. In
one embodiment, annular lumen 614 is a balloon inflation lumen.
[0140] The leads from the sensors may be attached on the surface of
an element of the balloon catheter without being enclosed in a
lumen. FIG. 5M shows a partial perspective view of a balloon
catheter comprising an outer member 616, an inner member 618 and a
balloon 620 attached to distal region of outer member 616 and
distal region of inner member 618. The balloon catheter further
comprises a first sensor 624 located on the distal region of outer
member 616 and a second sensor 626 located on the distal region of
inner member 618. Second sensor 626 comprises a lead 628. FIG. 5AB
shows a cross section through plane 5AB-5AB in FIG. 5M. Outer
member 616 comprises a first sensor lumen 630 to receive the lead
from first sensor 624. Inner member 618 comprises a circular lumen
632. Lead 628 from second sensor 626 is attached on the outer
surface of inner member 618 and is oriented parallel to inner
member 618. Outer member 616 and inner member 618 enclose an
annular lumen 634. In one embodiment, annular lumen 634 is a
balloon inflation lumen. The sensors mentioned in FIGS. 5U through
5AB can be electromagnetic sensors or sensors including but not
limited to location sensors, magnetic sensors, electromagnetic
coils, RF transmitters, mini-transponders, ultrasound sensitive or
emitting crystals, wire-matrices, micro-silicon chips, fiber-optic
sensors, etc.
[0141] FIGS. 6A through 6G illustrate partial perspective views of
several embodiments of shaft designs for the various devices
disclosed herein. These shaft designs are especially useful for
devices that encounter high torque or high burst pressures or
require enhanced pushability, steerability and kink resistance.
FIG. 6A shows a partial perspective view of an embodiment of a
shaft 602 comprising a spiral element 604 wound around the shaft.
Spiral element 604 can be made of suitable materials like metals
(e.g. SS316L, SS304) and polymers. In one embodiment, spiral
element 604 is in the form of round wire of diameter between 0.04
mm to 0.25 mm. In another embodiment, spiral element is in the form
of flat wire of cross section dimensions ranging from 0.03
mm.times.0.08 mm to 0.08 mm.times.0.25 mm. FIG. 6B shows a partial
perspective view of an embodiment of a shaft 606 comprising a
reinforcing filament 608. Reinforcing filament 608 is substantially
parallel to the axis of shaft 606. Shaft 606 with reinforcing
filament 608 can be covered with a jacketing layer. Reinforcing
filament 608 can be made of suitable materials like metals,
polymers, glass fiber etc. Reinforcing filament 608 can also have
shape memory characteristics. In one embodiment, reinforcing
filament 608 is embedded in shaft 606. In another embodiment,
reinforcing filament is introduced through a lumen in shaft 606.
Shaft 606 may comprise more than one reinforcing filament 608. FIG.
6C shows a partial perspective view of an embodiment of a shaft 610
comprising one of more stiffening rings 612 along the length of
shaft 610. FIG. 6D shows a partial perspective view of an
embodiment of a shaft 614 comprising a series of controllably
stiffening elements 616 along the length of the shaft. Shaft 614
further comprises a tension wire 618 that runs through controllably
stiffening elements 616 and is attached to the most distal
stiffening element. The tension in tension wire 618 causes
controllably stiffening elements 616 to come into contact with each
other with a force. Friction between controllably stiffening
elements 616 causes shaft 614 to have a certain stiffness.
Increasing the tension in tension wire 618 increases the force with
which controllably stiffening elements 616 come into contact with
each other. This increases the friction between controllably
stiffening elements 616 which in turn increases the stiffness of
shaft 614. Similarly, reducing the tension in tension wire 618
reduces the stiffness of shaft 614. Controllably stiffening
elements 616 can be made from suitable materials like metal,
polymers and composites. In one embodiment, controllably stiffening
elements 616 are separated from each other by one or more springs.
Tension wire 618 can be made from metals like SS316. Tension wire
618 may also be used to cause the device to actively bend or
shorten in response to tension. FIG. 6E shows a partial perspective
view of an embodiment of a shaft 620 comprising a hypotube 622. In
one embodiment, hypotube 622 is located on the exterior surface of
shaft 620. In another embodiment, hypotube 622 is embedded in shaft
620. Hypotube 620 can be made of metals like stainless steel 316 or
suitable polymers. FIGS. 6F and 6F' show a partial perspective view
of an embodiment of a shaft 624 comprising a reinforcing element
626 in the form of a reinforcing braid or mesh located on the outer
surface of shaft 624. Reinforcing element 626 can be made of
suitable materials like polymer filaments (e.g. PET or Kevlar
filaments), metallic wires e.g. SS316 wires etc. The braid pattern
can be regular braid pattern, diamond braid pattern, diamond braid
pattern with a half load etc. In one embodiment, the outer surface
of reinforcing element 626 is covered with a jacketing layer.
[0142] The shafts of various devices disclosed herein may be non
homogenous along their length. Examples of such shafts are
illustrated in FIGS. 6G through 6H. FIG. 6G shows a partial
perspective view of an embodiment of a device comprising a shaft
628 comprising a proximal portion 630, a distal portion 632, a
working element 634 and a plastically deformable region 636 located
between the proximal portion 630 and distal portion 632.
Plastically deformable region 636 can be deformed by a physician to
adjust the angle between proximal portion 630 and distal portion
632. This enables the devices to be used for several different
anatomical regions of the same patient. Also, such devices can be
adjusted for optimal navigation through a patient's anatomy. In one
embodiment, shaft 628 comprises multiple plastically deformable
regions. In another embodiment plastically deformable region 636 is
located within working element 634. Such a design comprising one or
more plastically deformable regions can be used for any of the
devices mentioned herein like catheters with working elements,
guide catheters, guide catheters with a pre-set shape, steerable
guide catheters, steerable catheters, guidewires, guidewires with a
pre-set shape, steerable guidewires, ports, introducers, sheaths
etc.
[0143] FIG. 6H shows a partial perspective view of an embodiment of
a device comprising a shaft with a flexible element. The design is
illustrated as a shaft 638 comprising a proximal portion 640, a
distal portion 642 and a working element 644 (e.g. a balloon).
Shaft 638 further comprises a flexible element 646 located between
proximal portion 640 and distal portion 642. This design enables
proximal portion 640 to bend with respect to distal portion 642
making it easier to navigate through the complex anatomy and
deliver working element 644 to the desired location. In one
embodiment, shaft 638 comprises multiple flexible elements. In
another embodiment, flexible element 646 is located within working
element 644. Such a design comprising one or more flexible elements
can be used for any of the devices mentioned herein like catheters
with working elements, guide catheters, guide catheters with a
pre-set shape, steerable guide catheters, steerable catheters,
guidewires, guidewires with a pre-set shape, steerable guidewires,
ports, introducers, sheaths etc.
[0144] FIGS. 6I through 6K illustrate an example of a shaft
comprising a malleable element. FIG. 6I shows a partial perspective
view of an embodiment of a shaft 648 comprising malleable element
650 and a lumen 652 wherein shaft 648 is in a substantially
straight configuration. Malleable element 650 is embedded in shaft
648 such that the axis of malleable element 650 is substantially
parallel to the axis of shaft 648. FIG. 6J shows a partial
perspective view of the embodiment of FIG. 6I in a bent
configuration. FIG. 6K shows a cross sectional view through plane
6K-6K of FIG. 6I showing shaft 648 comprising malleable element 650
and a lumen 652. In one embodiment, shaft 648 comprises more than
one malleable element.
[0145] FIGS. 6L through 6M show an embodiment of a controllably
deformable shaft. FIG. 6L shows a partial sectional view of an
embodiment of a controllably deformable shaft 654 comprising a pull
wire 656 attached to a pull wire terminator 658 located near the
distal end of shaft 654. FIG. 6M shows a partial sectional view of
the controllably deformable shaft 654 of FIG. 6L in a bent
orientation when pull wire 656 is pulled in the proximal direction.
The deformation can be varied by varying the location of pull wire
terminator 658 and the stiffness of various sections of shaft 658.
The stiffness of a section of shaft 658 can be varied by adding
reinforcing coatings, external or internal reinforcing coils,
reinforcing fabric, reinforcing meshes and reinforcing wires,
hinged elements, embedded filaments, reinforcing rings etc.
[0146] FIG. 6N shows a perspective view of a balloon catheter
comprising a rigid or semi-rigid member. The balloon catheter
comprises a rigid or semi-rigid member 660 and a balloon 662
located on the distal region of rigid or semi-rigid member 660.
Rigid or semi-rigid member 660 may comprise one or more lumens.
Rigid or semi-rigid member 660 may comprise one or more bent,
curved or angled regions. Balloon 662 is inflated by a balloon
inflation tube 664 comprising a hub 666 at the proximal end of
balloon inflation tube 664. In one embodiment, balloon inflation
tube 664 is fully attached along its length to rigid or semi-rigid
member 660. In another embodiment, balloon inflation tube 664 is
partially attached along its length to rigid or semi-rigid member
660.
[0147] FIGS. 6O through 6Q illustrate sectional views of a balloon
catheter comprising an insertable and removable element. FIG. 60
shows a balloon catheter 668 comprising a balloon 670, a first
lumen 672 and a balloon inflation lumen 674 opening into balloon
670 through an inflation port 676. FIG. 6P shows an insertable
element 678 having a proximal end 680 and a distal end 682. In one
embodiment, distal end 682 ends in a sharp tip for penetrating
tissue. In one embodiment, insertable element 678 comprises one or
more bent, angled or curved regions 684. Insertable element 678 can
be fabricated from a variety of materials to obtain properties
including but not limited to rigidity, shape memory, elasticity,
ability to be plastically deformed etc. In FIG. 6Q, insertable
element 678 is inserted into balloon catheter 668 through first
lumen 672. This combination can be used to perform a diagnostic or
therapeutic procedure. Insertable element 678 may be removed during
or after the procedure.
[0148] FIGS. 7A through 7K show cross sectional views of several
embodiments of lumen orientation in the devices disclosed herein.
FIG. 7A shows a cross sectional view of an embodiment of a shaft
702 comprising a first lumen 704 and a second lumen 706. In one
embodiment, first lumen 704 is a guidewire lumen and second lumen
706 is an inflation lumen. FIG. 7B shows a cross sectional view of
an embodiment of a shaft 708 comprising a first lumen 710 and a
annular second lumen 712 such that second annular lumen 712 is
substantially coaxial with first lumen 710. In one embodiment,
first lumen 710 is a guidewire lumen and annular second lumen 712
is an inflation lumen. FIG. 7C shows a cross sectional view of an
embodiment of a shaft 714 comprising a first tubular element 716
comprising a first lumen 718, a second tubular element 720
comprising a second lumen 722 and a jacket 724 surrounding first
tubular element 716 and second tubular element 720. In one
embodiment, first lumen 718 is a guidewire lumen and second lumen
722 is an inflation lumen. FIG. 7D shows a cross sectional view of
an embodiment of a shaft 726 comprising a first lumen 728, a second
lumen 730 and a third lumen 732. In one embodiment, first lumen 728
is a guidewire lumen, second lumen 730 is an irrigation/aspiration
lumen and third lumen 732 is an inflation lumen. FIG. 7E shows a
cross sectional view of an embodiment of a shaft 734 comprising a
cylindrical element 736, a tubular element 738 comprising a lumen
740 and a jacket 742 surrounding cylindrical element 736 and
tubular element 738. FIG. 7F shows a cross sectional view of an
embodiment of a shaft 744 comprising a tubular member 746
comprising a first lumen 748 and a second lumen 750; a first
coating 752 located on the outer surface of tubular member 746; a
braid 754 located on the outer surface of first coating 752 and a
second coating 756 surrounding braid 754. First lumen 748 is lined
with a suitable coating 758 like hydrophilic lubricious coating,
hydrophobic lubricious coating, abrasion resisting coating etc. In
one embodiment, first lumen 748 is a guidewire lumen and second
lumen 750 is an inflation lumen. The lumens disclosed herein can be
lined with suitable coatings like hydrophilic lubricious coatings,
hydrophobic lubricious coatings, abrasion resisting coatings,
radiopaque coatings, echogenic coatings etc.
[0149] FIG. 7G shows a partial perspective view of an embodiment of
a shaft 754* comprising a first lumen 756* and a zipper lumen 758*.
Zipper lumen 758* allows a device like a guidewire 760* to be
easily introduced into or removed from shaft 754*. FIG. 7H shows a
cross sectional view through plane 7H-7H in FIG. 7G showing the
orientations of first lumen 756* and zipper lumen 758*.
[0150] FIG. 7I shows a cross sectional view of an embodiment of a
shaft 762 comprising a first lumen 764 and a rapid exchange lumen
766. Rapid exchange lumen 766 extends from the distal end of shaft
762 to a proximal region. Rapid exchange lumen 766 enables shaft
762 to be easily and quickly introduced or removed over an exchange
device like a guidewire 768. FIG. 7J shows a cross sectional view
through plane 7J-7J in FIG. 7I showing first lumen 764 and rapid
exchange lumen 766. FIG. 7K shows a cross sectional view through
plane 7K-7K in FIG. 7I showing first lumen 764.
[0151] FIGS. 7L through 7Q shows perspective and sectional views of
lumens for the devices disclosed herein that are not present
throughout the length of the devices. FIG. 7L shows a perspective
view of a balloon catheter comprising a shaft 770, a balloon 772
and a lumen 774 that is present throughout shaft 770. The balloon
catheter further comprises a balloon inflation lumen 776 that opens
into balloon 772. The distal end of balloon inflation lumen 776 is
plugged with a plug 778. FIG. 7M shows a crossection through plane
7M-7M in FIG. 7L showing shaft 770 comprising lumen 774 and balloon
inflation lumen 776. FIG. 7N shows a crossection through plane
7N-7N in FIG. 7L showing shaft 770 comprising lumen 774 and plug
778. FIG. 7O shows a perspective view of a balloon catheter
comprising a shaft 780, a balloon 782 and a lumen 786 that is
present throughout shaft 780. The balloon catheter further
comprises a balloon inflation lumen 784. The distal end of balloon
inflation lumen 784 opens into balloon 782. FIG. 7P shows a
crossection through plane 7P-7P in FIG. 7O showing shaft 780
comprising lumen 786 and balloon inflation lumen 784. FIG. 7Q shows
a crossection through plane 7Q-7Q in FIG. 7O showing shaft 780
comprising lumen 786.
[0152] FIGS. 8A through 8E show partial perspective views of
several embodiments of markers that may be present on the elements
of the devices mentioned herein. FIG. 8A shows a partial
perspective view of an embodiment of a shaft 800 comprising a
plurality of distance markers 802 located along the length of shaft
800. FIG. 8B shows a partial perspective view of an embodiment of a
shaft 804 comprising a plurality of radiographic markers 806
located along the length of shaft 804. FIG. 8C shows a partial
perspective view of an embodiment of a shaft 808 comprising a
plurality of ring shaped radiographic markers 810 located along the
length of shaft 808. FIG. 8D shows a partial perspective view of an
embodiment of a balloon catheter 812 comprising a shaft 814 and a
balloon 816. Balloon 816 comprises a plurality of radiographic
markers 818 located on the outer surface of the balloon 816. Such
markers 818 may be in a linear arrangement, non-linear arrangement
or any other configuration that performs the desired marking
function (e.g., delineating the length and/or diameter of the
balloon, marking the proximal and/or distal ends of the balloon,
etc.). FIGS. 8E and 8E' show partial perspective and longitudinal
sectional views of an embodiment of a balloon catheter 820
comprising a shaft 822 and a balloon 824. Balloon 824 comprises a
plurality of radiographic markers 826 located on the inner surface
of the balloon 824. Such markers 826 may be in a linear
arrangement, non-linear arrangement or any other configuration that
performs the desired marking function (e.g., delineating the length
and/or diameter of the balloon, marking the proximal and/or distal
ends of the balloon, etc.). The devices disclosed herein may also
comprise several other types of markers like ultrasound markers,
radiofrequency markers and magnetic markers. Similarly, the devices
disclosed herein may also comprise one or more sensors like
electromagnetic sensors, electrical sensors, magnetic sensors,
light sensors and ultrasound sensors.
[0153] The term "diagnostic or therapeutic substance" as used
herein is to be broadly construed to include any feasible drugs,
prodrugs, proteins, gene therapy preparations, cells, diagnostic
agents, contrast or imaging agents, biologicals, etc. Such
substances may be in bound or free form, liquid or solid, colloid
or other suspension, solution or may be in the form of a gas or
other fluid or nan-fluid. For example, in some applications where
it is desired to treat or prevent a microbial infection, the
substance delivered may comprise pharmaceutically acceptable salt
or dosage form of an antimicrobial agent (e.g., antibiotic,
antiviral, antiparasitic, antifungal, etc.), a corticosteroid or
other anti-inflammatory (e.g., an NSAID), a decongestant (e.g.,
vasoconstrictor), a mucous thinning agent (e.g., an expectorant or
mucolytic), an agent that prevents of modifies an allergic response
(e.g., an antihistamine, cytokine inhibitor, leucotriene inhibitor,
IgE inhibitor, immunomodulator), etc. Other non-limiting examples
of diagnostic or therapeutic substances that may be useable in this
invention are described in copending U.S. patent application Ser.
No. 10/912,578 entitled Implantable Devices and Methods for
Delivering Drugs and Other Substances to Treat Sinusitis and Other
Disorders filed on Aug. 4, 2004, the entire disclosure of which is
expressly incorporated herein by reference.
[0154] The term "nasal cavity" used herein to be broadly construed
to include any cavity that is present in the anatomical structures
of the nasal region including the nostrils and paranasal
sinuses.
[0155] The term "trans-nasal" means through a nostril.
[0156] Although the methods and devices disclosed herein are
illustrated in conjunction with particular paranasal sinuses, it is
understood that these methods and devices can be used in other
paranasal sinuses as well as other anatomical passageways of the
ear, nose or throat.
[0157] Optionally, any of the working devices and guide catheters
described herein may be configured or equipped to receive or be
advanced over a guidewire or other guide member (e.g., an elongate
probe, strand of suure material, other elongate member) unless to
do so would render the device inoperable for its intended purpose.
Some of the specific examples described herein include guidewires,
but it is to be appreciated that the use of guidewires and the
incorporation of guidewire lumens is not limited to only the
specific examples in which guidewires or guidewire lumens are
shown. The guidewires used in this invention may be constructed and
coated as is common in the art of cardiology. This may include the
use of coils, tapered or non-tapered core wires, radioopaque tips
and/or entire lengths, shaping ribbons, variations of stiffness,
PTFE, silicone, hydrophilic coatings, polymer coatings, etc. For
the scope of this invention, these wires may possess dimensions of
length between 5 and 75 cm and outer diameter between 0.005'' and
0.050''.
[0158] Several modalities can be used with the devices and methods
disclosed herein for navigation and imaging of the devices within
the anatomy. For example, the devices disclosed herein may comprise
an endoscope for visualization of the target anatomy. The devices
may also comprise ultrasound imaging modalities to image the
anatomical passageways and other anatomical structures. The devices
disclosed herein may comprise one or more magnetic elements
especially on the distal end of the devices. Such magnetic elements
may be used to navigate through the anatomy by using external
magnetic fields. Such navigation may be controlled digitally using
a computer interface. The devices disclosed herein may also
comprise one or more markers (e.g. infra-red markers). The markers
can be used to track the precise position and orientation of the
devices using image guidance techniques. Several other imaging or
navigating modalities including but not limited to fluoroscopic,
radiofrequency localization, electromagnetic, magnetic and other
radiative energy based modalities may also be used with the methods
and devices disclosed herein. These imaging and navigation
technologies may also be referenced by computer directly or
indirectly to pre-existing or simultaneously created 3-D or 2-D
data sets which help the doctor place the devices within the
appropriate region of the anatomy.
[0159] The distal tip of devices mentioned herein may comprise a
flexible tip or a soft, atraumatic tip. Also, the shaft of such
devices may be designed for enhanced torquability.
[0160] The embodiments herein have been described primarily in
conjunction with minimally invasive procedures, but they can also
be used advantageously with existing open surgery or laparoscopic
surgery techniques.
[0161] It is to be appreciated that the invention has been
described hereabove with reference to certain examples or
embodiments of the invention but that various additions, deletions,
alterations and modifications may be made to those examples and
embodiments without departing from the intended spirit and scope of
the invention. For example, any element or attribute of one
embodiment or example may be incorporated into or used with another
embodiment or example, unless to do so would render the embodiment
or example unsuitable for its intended use. All reasonable
additions, deletions, modifications and alterations are to be
considered equivalents of the described examples and embodiments
and are to be included within the scope of the following
claims.
* * * * *